AzTrials
AzTrials

Castration-Sensitive Prostate CarcinomaPhase 3NCT06931340

Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial

A Phase 3 study testing Androgen Therapy, Apalutamide and Docetaxel in people with Castration-Sensitive Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by Alliance for Clinical Trials in Oncology at 214 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Androgen Therapy, Apalutamide and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,260 participants
Where
214 sitesUnited States
Study dates
1 Dec 2025to 8 May 2039
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documentation of disease:
  • Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology
  • Must have had evidence of metastatic disease (American Joint Committee on Cancer [AJCC] metastasis [M]1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as:
  • Bone metastases detected by CT, radionuclide technetium-99 (99Tc)- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria; OR
  • Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥ 15 mm) detected on CT or MRI as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Subjects with regional lymph node metastases only (nodes [N]1, below the aortic bifurcation) will not be eligible for the study; OR
  • Visceral or soft tissue metastases detected on CT or MRI as defined by RECIST version 1.1. Soft tissue/visceral lesions are measurable if the long axis diameter is ≥ 10 mm
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  • Evidence of metastatic disease by PSMA-PET only and not visible by CT, radionuclide bone scan, or MRI will not satisfy eligibility criteria
  • No metachronous low-volume disease (defined as recurrent metastatic disease after definitive treatment of prostate primary) and with ≤ 4 bone metastasis and no visceral metastasis on conventional imaging by CT, radionuclide 99Tc-biphosphonate bone scan, or MRI)
  • Next generation sequencing (NGS) results from any tissue based Clinical Laboratory Improvement Act (CLIA) test must be available at the time of registration. NGS from soft tissue or visceral lesion if available is preferred. NGS from bone or primary prostate will be accepted. Patients with failed NGS testing are not eligible
  • Prior treatment
  • ADT (luteinizing hormone-releasing hormone [LHRH] agonist/antagonist or orchiectomy) with or without first generation anti-androgen, or second-generation androgen receptor signaling inhibitor (ARSI) within 120 days of registration is permitted. No washout period will be needed for the first generation- androgen or ARSI prior to registration. Anti-androgen treatment is only permitted if used within 120 days of registration
  • No prior chemotherapy for prostate cancer
  • Age ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ 1 x upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is > 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1 × ULN, subject may be eligible)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate transaminase [SGT]) ≤ 1.5 x upper limit of normal (ULN)
  • Calculated (Calc.) creatinine clearance > 30 mL/min
  • Serum potassium ≥ 3.5 mmol/L
  • Comorbid conditions
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Leptomeningeal metastases: Patients with treated leptomeningeal metastases are eligible if follow-up brain imaging 30 days after central nervous system (CNS)-directed therapy shows no evidence of progression
  • HIV: Patients with known HIV infection on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial
  • Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • No seizure or known condition that may pre-dispose to seizure (e.g. prior stroke within 1 year to randomization, brain arteriovenous malformation or condition requiring CNS surgery or radiation therapy)
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class II or better. Any condition that in the opinion of the investigator, would preclude participation in this study. Patients with stable asymptomatic deep venous thromboembolism on stable anti-coagulation will be eligible
  • Hypertension: Subjects with uncontrolled hypertension as indicated by a resting systolic blood pressure (BP) >= 160 mmHg or diastolic BP >= 100 mmHg despite medical management are not permitted to register
  • Allergies: Subjects with known hypersensitivity to any of the study drugs, or excipients in the formulation of the study drugs are not permitted to register
  • Concomitant medications
  • Chronic concomitant treatment with strong inhibitors of cytochrome P450 3A4 (CYP3A4) is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug prior to registration on the study. See Section 8.1.9 for more information
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment
  • Medications known to lower the seizure threshold must be discontinued or substituted prior to study entry. See Section 8.1.9 for more information
  • Patient agrees to use a condom (even men with vasectomies) and another effective method of birth control if having sex with a woman of childbearing potential or agrees to use a condom if having sex with a woman who is pregnant while on study drug and for 3 months following the last dose of study drug. Must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study drug

Who cannot join

None listed.

Trial locations and contacts

214 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shiva Baghaie, MPH contact

(773) 702-9171

GUprotocols@alliancenctn.org

214 sites in 1 country

United States214 sites, 208 recruiting

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

    Site Public Contact, 515-239-4734, ksoder@mcfarlandclinic.com

    Joseph J. Merchant

    Recruiting

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

    Site Public Contact, 715-623-9869, Juli.Alford@aspirus.org

    Andrew J. Huang

    Recruiting

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

    Site Public Contact, 920-364-3604, ResearchDept@thedacare.org

    Joyce Philip

    Recruiting

  • Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton

    Appleton, Wisconsin, 54915

    Site Public Contact, AWRI.inquiry@ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Northside Hospital

    Atlanta, Georgia, 30342

    Site Public Contact, 404-303-3355, ClinicalTrials@northside.com

    Shailesh R. Satpute

    Recruiting

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

    Site Public Contact, 888-336-8262

    Jessica D. McDermott

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Kristine P. Lacuna

    Recruiting

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

    Site Public Contact, 218-333-5000, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

    Site Public Contact, 802-225-5400

    Rahul Anil

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

    Site Public Contact, 800-996-2663, research@billingsclinic.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

    Site Public Contact, 800-648-6274

    Wallace Jones

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

    Suspended

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield

    Brookfield, Wisconsin, 53045

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

    Site Public Contact, 800-767-9355, askroswell@roswellpark.org

    Ellis G. Levine

    Recruiting

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

    Site Public Contact, 802-656-4101, rpo@uvm.edu

    Rahul Anil

    Recruiting

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

    Site Public Contact, 802-656-8990, rpo@uvm.edu

    Rahul Anil

    Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Aultman Health Foundation

    Canton, Ohio, 44710

    Site Public Contact, 330-363-7274, ClinicalReserachDept@aultman.com

    Mehool A. Patel

    Recruiting

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

    Site Public Contact, 573-334-2230, sfmc@sfmc.net

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-365-4673

    Deborah W. Wilbur

    Recruiting

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

    Site Public Contact, 319-363-2690

    Deborah W. Wilbur

    Recruiting

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

    Site Public Contact, 304-388-9944, CAMCClinicalTrials@vandaliahealth.org

    Kok Hoe Chan

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Jefferson Cherry Hill Hospital

    Cherry Hill, New Jersey, 08002

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Kevin K. Zarrabi

    Recruiting

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

    Site Public Contact, 312-226-2371, Cancer_Studies@rush.edu

    Manan Shah

    Recruiting

  • University of Illinois

    Chicago, Illinois, 60612

    Site Public Contact, 312-355-3046

    Karine Tawagi

    Recruiting

  • Ascension Calumet Hospital-Chilton

    Chilton, Wisconsin, 53014

    Site Public Contact, AWRI.inquiry@ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Site Public Contact, 800-293-5066, Jamesline@osumc.edu

    Lingbin Meng

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Kristine P. Lacuna

    Recruiting

  • Guthrie Cortland Memorial Hospital

    Cortland, New York, 13045

    Site Public Contact, 607-756-3130

    Alina Basnet

    Recruiting

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • UT Southwestern Simmons Cancer Center - RedBird

    Dallas, Texas, 75237

    Site Public Contact, 214-648-7097, canceranswerline@utsouthwestern.edu

    Qian Qin

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Qian Qin

    Recruiting

  • Carle at The Riverfront

    Danville, Illinois, 61832

    Site Public Contact, 800-446-5532, Research@Carle.com

    Kendrith M. Rowland

    Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

    Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org

    Matthew J. Eadens

    Recruiting

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

    Site Public Contact, 815-285-7800

    Bryan A. Faller

    Recruiting

  • Bayhealth Hospital Kent Campus

    Dover, Delaware, 19901

    Active, not recruiting

  • Kaiser Permanente Dublin

    Dublin, California, 94568

    Site Public Contact, 877-642-4691

    Andrea L. Harzstark

    Recruiting

  • Northside Hospital - Duluth

    Duluth, Georgia, 30096

    Site Public Contact, 404-303-3355, Clinical.trials@northside.com

    Shailesh R. Satpute

    Recruiting

  • Durham VA Medical Center

    Durham, North Carolina, 27705

    Site Public Contact, 919-286-0411, VHADURcancertrials@va.gov

    Rhonda L. Bitting

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Site Public Contact, 888-275-3853

    Hannah D. McManus

    Recruiting

  • Shaw Cancer Center

    Edwards, Colorado, 81632

    Site Public Contact, 970-569-7429

    Erin Schwab

    Recruiting

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

    Site Public Contact, 800-446-5532, Research@carle.com

    Kendrith M. Rowland

    Recruiting

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

    Site Public Contact, 814-452-5000

    Shifeng S. Mao

    Recruiting

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-323-5760, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

    Site Public Contact, 701-234-6161, OncologyClinicalTrialsFargo@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • Hurley Medical Center

    Flint, Michigan, 48503

    Site Public Contact, 810-762-8038, wstrong@ghci.org

    Christopher M. Reynolds

    Recruiting

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • UT Southwestern/Simmons Cancer Center-Fort Worth

    Fort Worth, Texas, 76104

    Site Public Contact, 214-648-7097, canceranswerline@UTSouthwestern.edu

    Qian Qin

    Recruiting

  • Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson

    Franklin, Wisconsin, 53132

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Hematology Oncology Associates of Fredericksburg Inc

    Fredericksburg, Virginia, 22408

    Site Public Contact, 540-371-0079, cvaughn@hoafredericksburg.com

    Asit K. Paul

    Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente Fresno Orchard Plaza

    Fresno, California, 93720

    Site Public Contact, 833-574-2273

    Andrea L. Harzstark

    Recruiting

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting

  • Malcom Randall Veterans Administration Medical Center

    Gainesville, Florida, 32610

    Site Public Contact, 352-273-8675, trials@cancer.ufl.edu

    Jess DeLaune

    Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Saint Mary's Hospital and Regional Medical Center

    Grand Junction, Colorado, 81501

    Site Public Contact, 303-777-2663, ccrp@co-cancerresearch.org

    Wallace Jones

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Stephen H. Dyar

    Recruiting

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

    Site Public Contact, 864-603-6234, Heather_Rich@bshsi.org

    Stephen H. Dyar

    Recruiting

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

    Site Public Contact, 864-725-4771, nmcgaha@selfregional.org

    Albert C. Lockhart

    Recruiting

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Kristine P. Lacuna

    Recruiting

  • HaysMed

    Hays, Kansas, 67601

    Site Public Contact, 785-623-5774

    Elizabeth M. Wulff

    Recruiting

  • Edward Hines Jr VA Hospital

    Hines, Illinois, 60141

    Site Public Contact, 708-202-8387

    Elizabeth Henry

    Recruiting

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

    Site Public Contact, 808-432-5195, shelley.a.clark@kp.org

    Andrea L. Harzstark

    Recruiting

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

    Suspended

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

    Site Public Contact, 412-359-3043, ddefazio@wpahs.org

    Shifeng S. Mao

    Recruiting

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • University Health Truman Medical Center

    Kansas City, Missouri, 64108

    Site Public Contact, 816-404-4375

    Elizabeth M. Wulff

    Recruiting

  • University of Kansas Cancer Center - Briarcliff

    Kansas City, Missouri, 64116

    Site Public Contact, 913-588-3671

    Elizabeth M. Wulff

    Recruiting

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

    Site Public Contact, 858-822-5354, cancercto@ucsd.edu

    Yu-Wei Chen

    Recruiting

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado, 80026

    Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org

    Matthew J. Eadens

    Recruiting

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

    Site Public Contact, 517-364-3712, harsha.trivedi@umhsparrow.org

    Christopher M. Reynolds

    Recruiting

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

    Site Public Contact, 785-505-2800, Stephanie.Norris@LMH.ORG

    Elizabeth M. Wulff

    Recruiting

  • Northside Hospital - Gwinnett

    Lawrenceville, Georgia, 30046

    Site Public Contact, 404-303-3355, Clinical.trials@northside.com

    Shailesh R. Satpute

    Recruiting

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Kaiser Permanente-Lone Tree

    Lone Tree, Colorado, 80124

    Site Public Contact, 303-817-9295, KPCOIHRClinicalResearch@kp.org

    Matthew J. Eadens

    Recruiting

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • William S Middleton VA Medical Center

    Madison, Wisconsin, 53705

    Site Public Contact, 608-256-1901 ext. 17007

    David Kosoff

    Recruiting

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

    Site Public Contact, 800-446-5532, Research@carle.com

    Kendrith M. Rowland

    Recruiting

  • Aspirus Medford Hospital

    Medford, Wisconsin, 54451

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Deepak Kilari

    Recruiting

  • Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon

    Mequon, Wisconsin, 53097

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Kristine P. Lacuna

    Recruiting

  • Bayhealth Hospital Sussex Campus

    Milford, Delaware, 19963

    Active, not recruiting

  • Ascension Columbia Saint Mary's Hospital-Milwaukee Campus

    Milwaukee, Wisconsin, 53211

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Deepak Kilari

    Recruiting

  • Zablocki Veterans Administration Medical Center

    Milwaukee, Wisconsin, 53295

    Site Public Contact, 888-469-6614

    Sumana Devata

    Recruiting

  • Community Medical Center

    Missoula, Montana, 59804

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Kaiser Permanente- Modesto MOB II

    Modesto, California, 95356

    Site Public Contact, 877-642-4691

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

    Site Public Contact, 412-858-7746

    Shifeng S. Mao

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Kristine P. Lacuna

    Recruiting

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

    Site Public Contact, 618-899-1894, gayla.hall@ssmhealth.com

    Jay W. Carlson

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Site Public Contact, 801-507-3950, officeofresearch@imail.org

    Wallace Jones

    Recruiting

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

    Site Public Contact, 208-381-2774, eslinget@slhs.org

    Alison K. Conlin

    Recruiting

  • Allegheny Valley Hospital

    Natrona Heights, Pennsylvania, 15065

    Site Public Contact, Dawnmarie.DeFazio@ahn.org

    Shifeng S. Mao

    Recruiting

  • Froedtert and MCW Moorland Reserve Health Center

    New Berlin, Wisconsin, 53151

    Site Public Contact, 414-805-0505

    Deepak Kilari

    Recruiting

  • Mount Sinai Hospital

    New York, New York, 10029

    Site Public Contact, 212-824-7309, CCTO@mssm.edu

    Eric J. Miller

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Kristine P. Lacuna

    Recruiting

  • Carle BroMenn Medical Center

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Kendrith M. Rowland

    Recruiting

  • Carle Cancer Institute Normal

    Normal, Illinois, 61761

    Site Public Contact, 800-446-5532, Research@Carle.com

    Kendrith M. Rowland

    Recruiting

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

    Site Public Contact, 217-876-4762, morganthaler.jodi@mhsil.com

    Bryan A. Faller

    Recruiting

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    Deepak Kilari

    Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

    Site Public Contact, 920-433-8889, WI_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

    Site Public Contact, 801-387-7426, officeofresearch@imail.org

    Wallace Jones

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Site Public Contact, 405-271-8777, ou-clinical-trials@ouhsc.edu

    Adanma Anji Ayanambakkam Attanathi

    Recruiting

  • The University of Kansas Cancer Center - Olathe

    Olathe, Kansas, 66061

    Site Public Contact, 913-588-1569, OlatheCCResearch@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh

    Oshkosh, Wisconsin, 54904

    Site Public Contact, AWRI.inquiry@ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • University of Kansas Cancer Center-Overland Park

    Overland Park, Kansas, 66210

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Kevin K. Zarrabi

    Recruiting

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Kevin K. Zarrabi

    Recruiting

  • Jefferson Methodist Hospital

    Philadelphia, Pennsylvania, 19148

    Suspended

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

    Site Public Contact, 910-715-3500, jcwilliams@firsthealth.org

    Charles S. Kuzma

    Recruiting

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

    Site Public Contact, 877-284-2000

    Shifeng S. Mao

    Recruiting

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

    Site Public Contact, 412-578-5000

    Shifeng S. Mao

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • Ascension All Saints Hospital-Spring Street-Racine

    Racine, Wisconsin, 53405

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

    Site Public Contact, 760-834-3798

    Delshad Ahmad

    Recruiting

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

    Active, not recruiting

  • Aspirus Cancer Care-Rhinelander-James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • UT Southwestern Clinical Center at Richardson/Plano

    Richardson, Texas, 75080

    Site Public Contact, 972-669-7044, Suzanne.cole@utsouthwestern.edu

    Qian Qin

    Recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235

    Site Public Contact, ctoclinops@vcu.edu

    Asit K. Paul

    Recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Site Public Contact, 804-628-6430, CTOclinops@vcu.edu

    Asit K. Paul

    Recruiting

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814

    Site Public Contact, 877-642-4691, kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Coborn Cancer Center at Saint Cloud Hospital

    Saint Cloud, Minnesota, 56303

    Site Public Contact, 877-229-4907, coborncancercenter@centracare.com

    Donald J. Jurgens

    Recruiting

  • Salina Regional Health Center

    Salina, Kansas, 67401

    Site Public Contact, 785-452-7038, mleepers@srhc.com

    Elizabeth M. Wulff

    Recruiting

  • LDS Hospital

    Salt Lake City, Utah, 84143

    Site Public Contact, 801-408-1347, officeofresearch@imail.org

    Wallace Jones

    Recruiting

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Site Public Contact, rhabbaba@health.ucsd.edu

    Yu-Wei Chen

    Recruiting

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

    Site Public Contact, 406-969-6060, mccinfo@mtcancer.org

    John M. Schallenkamp

    Recruiting

  • Intermountain Health Alta View Hospital

    Sandy City, Utah, 84094

    Site Public Contact, IntermountainResearch@imail.org

    Wallace Jones

    Recruiting

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Guthrie Medical Group PC-Robert Packer Hospital

    Sayre, Pennsylvania, 18840

    Site Public Contact, 800-836-0388

    Joyson Poulose

    Recruiting

  • Sidney Kimmel Cancer Center Washington Township

    Sewell, New Jersey, 08080

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Kevin K. Zarrabi

    Recruiting

  • Saint Vincent Hospital Cancer Center at Sheboygan

    Sheboygan, Wisconsin, 53081

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Sheboygan Physicians Group

    Sheboygan, Wisconsin, 53081

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • Memorial Hospital East

    Shiloh, Illinois, 62269

    Site Public Contact, 314-747-9912, dschwab@wustl.edu

    Eric M. Knoche

    Recruiting

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

    Site Public Contact, 605-312-3320, OncologyClinicTrialsSF@sanfordhealth.org

    Daniel Almquist

    Recruiting

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

    Site Public Contact, 605-312-3320, OncologyClinicalTrialsSF@SanfordHealth.org

    Daniel Almquist

    Recruiting

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

    Site Public Contact, 217-545-7929

    Bryan A. Faller

    Recruiting

  • Springfield Clinic

    Springfield, Illinois, 62702

    Site Public Contact, 800-444-7541

    Bryan A. Faller

    Recruiting

  • Springfield Memorial Hospital

    Springfield, Illinois, 62781

    Site Public Contact, 217-528-7541, pallante.beth@mhsil.com

    Bryan A. Faller

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Veteran's Affairs Medical Center - Saint Louis

    St Louis, Missouri, 63125

    Site Public Contact, 773-702-9171, protocols@AllianceNCTN.org

    Eric M. Knoche

    Recruiting

  • Mercy Hospital South

    St Louis, Missouri, 63128

    Site Public Contact, 314-525-6042, Danielle.Werle@mercy.net

    Jay W. Carlson

    Recruiting

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

    Site Public Contact, 800-600-3606, info@siteman.wustl.edu

    Eric M. Knoche

    Recruiting

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

    Site Public Contact, 314-251-7066

    Jay W. Carlson

    Recruiting

  • Saint George Regional Medical Center

    St. George, Utah, 84770

    Site Public Contact, 833-321-3332, officeofresearch@imail.org

    Wallace Jones

    Recruiting

  • Aspirus Cancer Care - Stevens Point

    Stevens Point, Wisconsin, 54481

    Site Public Contact, 715-847-2353, Beth.Knetter@aspirus.org

    Andrew J. Huang

    Recruiting

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

    Site Public Contact, 800-862-2215

    Judy Huang

    Recruiting

  • Saint Vincent Hospital Cancer Center at Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235-1495

    Site Public Contact, 920-433-8889, wi_research_admin@hshs.org

    Anthony J. Jaslowski

    Recruiting

  • ProMedica Flower Hospital

    Sylvania, Ohio, 43560

    Site Public Contact, 419-824-1842, PCIOncResearch@promedica.org

    Jeffrey H. Muler

    Recruiting

  • VCU Health Tappahannock Hospital

    Tappahannock, Virginia, 22560

    Site Public Contact, klcampbell@vcu.edu

    Asit K. Paul

    Recruiting

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

    Site Public Contact, 785-295-8000

    Elizabeth M. Wulff

    Recruiting

  • Banner University Medical Center - Tucson

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Edward P. Gelmann

    Recruiting

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

    Site Public Contact, UACC-IIT@uacc.arizona.edu

    Edward P. Gelmann

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Site Public Contact, 212-639-7592

    Kristine P. Lacuna

    Recruiting

  • Carle Cancer Center

    Urbana, Illinois, 61801

    Site Public Contact, 800-446-5532, Research@carle.com

    Kendrith M. Rowland

    Recruiting

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596

    Site Public Contact, 877-642-4691, Kpoct@kp.org

    Andrea L. Harzstark

    Recruiting

  • Illinois CancerCare - Washington

    Washington, Illinois, 61571

    Site Public Contact, 309-243-3605, andersonj@illinoiscancercare.com

    Bryan A. Faller

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Site Public Contact, 202-444-2223

    Suthee Rapisuwon

    Recruiting

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

    Site Public Contact, 202-877-8839

    Suthee Rapisuwon

    Recruiting

  • Aspirus Cancer Care-Wausau

    Wausau, Wisconsin, 54401

    Site Public Contact, 877-405-6866

    Andrew J. Huang

    Recruiting

  • Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa

    Wauwatosa, Wisconsin, 53226

    Site Public Contact, AWRI.Inquiry@Ascension.org

    Kamal Kant Singh Abbi

    Recruiting

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

    Site Public Contact, 414-805-0505

    Deepak Kilari

    Recruiting

  • University of Kansas Hospital-Westwood Cancer Center

    Westwood, Kansas, 66205

    Site Public Contact, 913-588-3671, KUCC_Navigation@kumc.edu

    Elizabeth M. Wulff

    Recruiting

  • Wexford Health and Wellness Pavilion

    Wexford, Pennsylvania, 15090

    Site Public Contact, Dawnmarie.DeFazio@ahn.org

    Shifeng S. Mao

    Recruiting

  • Asplundh Cancer Pavilion

    Willow Grove, Pennsylvania, 19090

    Site Public Contact, 215-600-9151, ONCTrialNow@jefferson.edu

    Kevin K. Zarrabi

    Recruiting

  • Aspirus Cancer Care - Wisconsin Rapids

    Wisconsin Rapids, Wisconsin, 54494

    Site Public Contact, 715-422-7718

    Andrew J. Huang

    Recruiting

  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

    Ypsilanti, Michigan, 48197

    Site Public Contact, 734-712-7251, MCRCwebsitecontactform@stjoeshealth.org

    Christopher M. Reynolds

    Recruiting

Other trials in United States

About this study

Official title: Docetaxel Addition in Metastatic Castrate-Sensitive Prostate Cancer (ASPIRE)

This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men with metastatic castrate sensitive prostate cancer.

SECONDARY OBJECTIVES:

  1. To determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves overall survival for men whose cancers have loss or inactivating mutations of TP53, PTEN, or RB1.

II. To determine if the addition of docetaxel to ADT plus apalutamide improves the time to radiographic progression per Prostate Cancer Working Group 3 (PCWG3) guidelines.

III. To determine the time to castration-resistant prostate cancer (CRPC) between arms.

IV. To determine symptomatic skeletal event free survival (SSE-FS) between arms.

  1. To determine the safety and tolerability of the triplet versus doublet using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.

VI. To determine radiographic progression free survival (rPFS), and overall survival (OS) in patients by the stratification factors a) volume/timing of disease (metachronous high volume, synchronous high volume, and synchronous low volume metastases on conventional imaging) and b) tumor suppressor gene alteration status (0 versus [vs] 1 vs 2+) between arms.

VII. To determine prostate specific antigen (PSA) 90 response rate at 6 weeks and 6 months between arms.

VIII. To determine time to PSA progression by PCWG3 criteria between arms. IX. To determine objective response rate (ORR) in patients with measurable disease between arms.

EXPLORATORY OBJECTIVES:

  1. To determine the time to worsening of physical symptoms of disease based on functional assessment of cancer therapy/National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire (NCCN-FACT FPSI-17) between arms.

II. To compare quality of life as measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) trial outcome index in patients with metastatic castrate-sensitive prostate cancer (mCSPC) who receive ADT + apalutamide + docetaxel vs ADT + apalutamide at the 24-month time point.

III. To compare quality of life as measured by other scales of the FACT-P in the two arms.

IV. To compare quality of life as measured by FACT-P total outcome index in the two arms at other timepoints.

  1. To compare pain severity and interference as measured by the Brief Pain Inventory Short Form (BPI-SF) in the two arms.

VI. To compare quality-adjusted life years which accounts for survival and utility (measured by European Quality of Life Five Dimension Five Level Scale [EQ-5D-5L]) in the two arms.

VII. To correlate baseline volume of disease on prostate-specific membrane antigen-positron emission tomography/computed tomography (PSMA-PET/CT) with baseline volume of disease on conventional imaging (CI).

VIII. To determine if baseline PSMA-PET/CT and CI are individually and jointly associated with OS, progression-free survival (PFS), PSA90 response, and PSA < 0.2 ng/ml after 6 months, and to estimate its clinical relevance when compared to these well characterized prognostic endpoints.

IX. To correlate 6-month PSA level with the presence/absence and volume of residual disease on PSMA-PET/CT after 6 months of doublet or triplet therapy.

  1. To correlate the concordance of radiographic progression on CI versus PSMA-PET/CT at the time of PSA progression.

XI. To determine rPFS, time to castration resistance, OS based on thresholds of volume of disease, and prostate-specific membrane antigen (PSMA) uptake (standardized uptake value [SUV]) based on baseline PSMA-PET/CT scan.

XII. To compare rPFS, time to castration resistance, and OS between arms in patients with de novo metastatic disease having received primary directed radiation therapy.

XIII. To determine rPFS, time to castration resistance, and OS correlation with PSA response at 6 weeks and 6 months.

XIV. To compare the impact of treatment on aging trajectory, as measured by the change in Deficit-Accumulation Frailty Index (DAFI) from baseline, 6- and 12-months, in the two arms.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive ADT at the discretion of the investigator and apalutamide orally (PO) once daily (QD). Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) scan or magnetic resonance imaging (MRI) and bone scan throughout the study. Patients may optionally undergo prostate-specific membrane antigen-positron emission tomography (PSMA-PET) scans and blood sample collection throughout the study.

ARM 2: Patients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel intravenously (IV) over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 6 months for up to 10 years.

Being tested
Androgen Therapy, Apalutamide, Docetaxel, Computed Tomography, Magnetic Resonance Imaging
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Androgen TherapyDrug

    Given ADT

  • ApalutamideDrug

    Given PO

  • DocetaxelDrug

    Also called Taxotere

    Given IV

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, CT Scan

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called MRI

    Undergo MRI

  • Bone ScanProcedure or surgery

    Undergo Bone Scan

  • PSMA PET ScanProcedure or surgery

    Undergo PSMA PET Scan

  • Biospecimen CollectionProcedure or surgery

    Undergo blood sample collection

  • Questionnaire AdministrationOther

    undergo Questionnaire Administration

Study groups in NCT06931340
Study groupRoleWhat they receive
Arm 1 (ADT, apalutamide)Active comparatorPatients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.
Receives: Drug: Androgen Therapy; Drug: Apalutamide; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: Biospecimen Collection; Other: Questionnaire Administration
Arm 2 (ADT, apalutamide, docetaxel)ExperimentalPatients receive ADT at the discretion of the investigator and apalutamide PO QD. Cycles repeat every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive docetaxel IV over 1 hour every 21 days for up to 6 doses. Additionally, patients undergo CT scan or MRI and bone scan throughout the study. Patients may optionally undergo PSMA-PET scans and blood sample collection throughout the study.
Receives: Drug: Androgen Therapy; Drug: Apalutamide; Drug: Docetaxel; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: Biospecimen Collection; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

    Will determine OS. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS.

    Measured: From randomization to death due to any cause, assessed up to 10 years

Secondary outcomes (11)

  1. Overall Survival (OS)

    Will determine if the addition of docetaxel to androgen deprivation therapy and apalutamide improves OS for men whose cancers have alterations of P53, PTEN, or RB1. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS.

    Measured: From randomization to death due to any cause, assessed up to 10 years

  2. Radiographic progression

    Will determine the time to radiographic progression- per Prostate Cancer Working Group (PCWG3) guidelines. Tumor response will be assessed utilizing imaging measurements, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population.

    Measured: From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years

  3. Castration-resistant prostate cancer (CRPC)

    Will determine the time to CRPC

    Measured: Time to prostate-specific antigen progression with serum testosterone being at castrate level < 0.50 ng/mL, or the time to progression by soft tissue/visceral lesions or time to progression by bone lesions per PCWG3 guidelines, assessed up to 10 years

  4. Symptomatic skeletal event free survival (SSE-FS)

    Will determine SSE-FS. An SSE is defined as external beam radiation therapy to relieve skeletal symptoms, or new symptomatic pathologic bone fracture, or occurrence of spinal cord compression or tumor-related orthopedic surgical intervention, whichever comes first

    Measured: From randomization to first occurrence of SSE or death from any cause, assessed up to 10 years

  5. Worsening of physical symptoms of disease

    Will determine the time to worsening of physical symptoms of disease based on functional assessment of cancer therapy / National Comprehensive Cancer Network prostate cancer symptom index 17 item questionnaire.

    Measured: up to 10 years

  6. Incidence of adverse events

    Will determine the safety and tolerability of the triplet versus doublet using Common Terminology Criteria for Adverse Events version 5.0.

    Measured: up to 10 years

  7. Radiographic progression free survival (rPFS)

    Will determine rPFS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. Tumor response will be assessed utilizing imaging measurements, as defined by RECIST 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population. Evaluation of rPFS will be assessed by the investigator.

    Measured: From randomization to first documentation of radiographic progressive disease or death due to any cause, assessed up to 10 years

  8. OS

    Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the triplet therapy, a group sequential efficacy/futility monitoring design will be employed. The planned analyses for OS will be tested using a one-sided type 1 error rate of 0.025. An intent-to-treat approach will be used to evaluate OS between treatments. The stratified logrank test will be the primary analysis to compare OS between treatments. The Kaplan-Meier estimate will be used to evaluate the within treatment OS distributions. In addition, the proportional hazards model will be applied to assess the treatment comparison adjusting for important covariates in predicting OS.

    Measured: Will determine OS in patients by the stratification factors a) timing/volume of disease 1) metachronous high volume, 2) synchronous high volume and 3) synchronous low volume metastases on conventional imaging. To assess the potential OS benefit from the

  9. Prostate specific antigen (PSA) 90 response rate

    Will determine PSA 90 response rate.

    Measured: At 6 weeks and 6 months

  10. Time to PSA progression

    Will determine PSA progression. PSA progression is defined as a ≥ 25% increase above the nadir (lowest screening or baseline) value, which is confirmed by a second value 3 or more weeks later, and an increase in absolute value of ≥ 2 ng/mL above nadir, at least 12 weeks from baseline. Subjects without PSA progression as of database cut-off, whether or not surviving, will be censored at the last total PSA lab assessment date.

    Measured: From randomization to the date of PSA progression based on PCWG3 criteria, assessed up to 10 years

  11. Objective response rate (ORR)

    Will determine ORR in patients with measurable disease. Tumor response will be assessed utilizing imaging measurements, as defined by RECIST 1.1. In this study, RECIST has been modified based on PCWG3 criteria, which are specific for this patient population

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2025
  2. Study start1 Dec 2025
  3. Primary completion11 Nov 2031 (estimated)
  4. Study completion8 May 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06931340
Sponsor's protocol ID
A032302
Other IDs
NCI-2025-00838
Status last verified
Nov 2026
First submitted
9 Apr 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Androgen Therapy, Apalutamide and Docetaxel in people with Castration-Sensitive Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by Alliance for Clinical Trials in Oncology at 214 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 214 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shiva Baghaie, MPH ((773) 702-9171, GUprotocols@alliancenctn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: From randomization to death due to any cause, assessed up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06931340.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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