AzTrials
AzTrials

Metastatic Castration-Resistant Prostate CarcinomaPhase 3NCT07200830

Testing Different Dosing Schedules of the Anti-cancer Drug, Lutetium 177Lu PSMA RLT and Its Effect on Patients With Advanced Prostate Cancer, RECIPROCAL Trial

A Phase 3 study testing Lutetium Lu 177 Vipivotide Tetraxetan, Biospecimen Collection and Patient Monitoring in people with Metastatic Castration-Resistant Prostate Carcinoma and Metastatic Prostate Adenocarcinoma, run by Alliance for Clinical Trials in Oncology at 138 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

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Trial summary

This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Lutetium Lu 177 Vipivotide Tetraxetan, Biospecimen Collection and Patient Monitoring
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,524 participants
Where
138 sitesUnited States
Study dates
31 Mar 2026to 9 Sep 2034
Phase
Phase 3

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

  • PRE-REGISTRATION (STEP 0): Patients must have histological, pathological, and/or cytological confirmation of prostate adenocarcinoma
  • PRE-REGISTRATION (STEP 0): Patients must have a positive PSMA PET/CT scan (either gallium Ga 68 gozetotide [68Ga-PSMA-11], fluorine F 18 piflufolastat [18F- DCFPyl], or fluorine F 18 flotufolastat gallium [18F-rhPSMA-7.3]), as defined as uptake greater than liver with no PSMA negative measurable soft tissue disease
  • PRE-REGISTRATION (STEP 0): PSA greater than 2.0 ng/mL
  • PRE-REGISTRATION (STEP 0): Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
  • Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL
  • Soft-tissue progression defined as an increase ≥ 20% in the sum of the diameter (SOD) (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest SOD since treatment started or the appearance of one or more new lesions
Show all 40Show fewer
  • Progression of bone disease: evaluable disease or new bone lesions(s) by bone scan (2+2 Prostate Cancer Clinical Trials Working Group 3 [PCWG3] criteria, Scher et al 2016)
  • PRE-REGISTRATION (STEP 0): Patients must have prior orchiectomy and/or ongoing androgen-deprivation therapy and a castrate level of serum testosterone (< 50 ng/dL or < 1.7 nmol/L)
  • PRE-REGISTRATION (STEP 0): Patients must have received at least one androgen receptor pathway inhibitor (ARPI) (to include either apalutamide, darolutamide, enzalutamide, or abiraterone)
  • ARPI must be stopped at least 4 weeks prior to pre-registration
  • PRE-REGISTRATION (STEP 0): Patients must not have previously received a taxane based chemotherapy regimen for mCRPC. Prior docetaxel for metastatic hormone-sensitive prostate carcinoma (mHSPC) or in the neoadjuvant or adjuvant setting is permitted if completed at least 12 months prior to pre-registration
  • PRE-REGISTRATION (STEP 0): Patients must have recovered to ≤ grade 2 from all clinically significant toxicities related to prior therapies (i.e. prior chemotherapy, radiation, immunotherapy, etc.)
  • PRE-REGISTRATION (STEP 0): Patients on a stable bisphosphonate or denosumab regimen for ≥ 30 days prior to pre-registration are eligible
  • PRE-REGISTRATION (STEP 0): Previous treatment with strontium Sr-89 (strontium-89), samarium Sm-153 (samarium-153), rhenium Re 186 (rhenium-186), rhenium Re 188 (rhenium-188), radium Ra 223 (radium-223) or hemi-body irradiation within 6 months prior to pre-registration is not allowed. Previous PSMA-targeted radioligand therapy is not allowed
  • PRE-REGISTRATION (STEP 0): Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy [including monoclonal antibodies]) within 28 days prior to pre-registration is not allowed
  • PRE-REGISTRATION (STEP 0): Age ≥ 18 years
  • PRE-REGISTRATION (STEP 0): Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • PRE-REGISTRATION (STEP 0): Platelet count ≥ 100,000/mm^3
  • PRE-REGISTRATION (STEP 0): Total bilirubin < 1.5 x upper limit of normal (ULN) or < 3 x ULN in patients with Gilbert's syndrome
  • PRE-REGISTRATION (STEP 0): Creatinine clearance estimated glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation
  • PRE-REGISTRATION (STEP 0): No acute biliary or urinary obstruction
  • PRE-REGISTRATION (STEP 0): Patients with treated/stable brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
  • Patients with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired. For patients with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain (MRI preferred or CT with contrast)
  • PRE-REGISTRATION (STEP 0): 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
  • PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • PRE-REGISTRATION (STEP 0): 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
  • PRE-REGISTRATION (STEP 0): 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
  • PRE-REGISTRATION (STEP 0): No investigational agents within 28 days prior to pre-registration
  • PRE-REGISTRATION (STEP 0): No other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy
  • PRE-REGISTRATION (STEP 0): No known hypersensitivity to the components of the study therapy or its analogs
  • PRE-REGISTRATION (STEP 0): No transfusion within 30 days of pre-registration
  • PRE-REGISTRATION (STEP 0): No symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression
  • PRE-REGISTRATION (STEP 0): Ability to read and comprehend English or Spanish
  • REGISTRATION (STEP 1): Completion of 2 doses of 177Lu PSMA RLT
  • REGISTRATION (STEP 1): PSA decline ≥ 50% between C1 D1 (screening) and C2 D22 +/-3 days
  • REGISTRATION (STEP 1): ECOG Performance Status ≤ 2
  • REGISTRATION (STEP 1): Absolute neutrophil count (ANC) ≥ 1,500/mm^3
  • REGISTRATION (STEP 1): Platelet count ≥ 100,000/mm^3
  • REGISTRATION (STEP 1): Creatinine clearance eGFR ≥ 40 mL/min/1.73m^2 using the Modification of Diet in Renal Disease (MDRD) equation

Who cannot join

None listed.

Trial locations and contacts

138 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

138 sites in 1 country

United States138 sites, 93 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

    Suspended

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

    Suspended

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

    Suspended

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

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

    Samir Narayan

    Recruiting

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

    Site Public Contact, 720-848-0650

    Elizabeth R. Kessler

    Recruiting

  • AIS Cancer Center at San Joaquin Community Hospital

    Bakersfield, California, 93301

    Site Public Contact, 661-323-4673

    Luis Mariscal

    Recruiting

  • Maryland Proton Treatment Center

    Baltimore, Maryland, 21201

    Site Public Contact, 410-369-5226, info@mdproton.com

    Zaker H. Rana

    Recruiting

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Site Public Contact, 800-888-8823

    Zaker H. Rana

    Recruiting

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

    Site Public Contact, 212-639-7592

    Deaglan McHugh

    Recruiting

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

    Site Public Contact, 443-643-3010

    Zaker H. Rana

    Recruiting

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

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

    John M. Schallenkamp

    Recruiting

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

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

    Daniel Almquist

    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

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Clara Hwang

    Recruiting

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

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

    Ellis G. Levine

    Recruiting

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

    Suspended

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

    Suspended

  • AtlantiCare Health Park-Cape May Court House

    Cape May Court House, New Jersey, 08210

    Site Public Contact, 609-677-7735

    James C. Wurzer

    Recruiting

  • Saint Anthony Regional Hospital

    Carroll, Iowa, 51401

    Suspended

  • Memorial Hospital of Laramie County

    Cheyenne, Wyoming, 82001

    Suspended

  • Northwestern University

    Chicago, Illinois, 60611

    Site Public Contact, 312-695-1301, cancer@northwestern.edu

    Michael Liu

    Recruiting

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

    Site Public Contact, 216-778-7559, ababal@metrohealth.org

    Joseph Attallah

    Recruiting

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Clara Hwang

    Recruiting

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

    Suspended

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

    Suspended

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

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

    John M. Schallenkamp

    Recruiting

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

    Site Public Contact, 719-365-2406

    Elizabeth R. Kessler

    Recruiting

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

    Site Public Contact, 719-364-6700

    Elizabeth R. Kessler

    Recruiting

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

    Site Public Contact, 443-546-1300

    Zaker H. Rana

    Recruiting

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

    Site Public Contact, 212-639-7592

    Deaglan McHugh

    Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

    Suspended

  • Henry Ford Medical Center-Fairlane

    Dearborn, Michigan, 48126

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Clara Hwang

    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

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Michael Liu

    Recruiting

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

    Site Public Contact, 515-241-6727

    Seema Harichand-Herdt

    Recruiting

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

    Suspended

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

    Suspended

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

    Suspended

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Clara Hwang

    Recruiting

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

    Site Public Contact, 410-822-1000, Christina.weisenborn@umm.edu

    Zaker H. Rana

    Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Suspended

  • Swedish Cancer Institute-Edmonds

    Edmonds, Washington, 98026

    Suspended

  • AtlantiCare Surgery Center

    Egg Harbor, New Jersey, 08234

    Site Public Contact, 609-748-7200

    James C. Wurzer

    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

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

    Suspended

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Michael Liu

    Recruiting

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

    Site Public Contact, 410-553-8100

    Zaker H. Rana

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

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

    John M. Schallenkamp

    Recruiting

  • Great Falls Clinic

    Great Falls, Montana, 59405

    Suspended

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

    Site Public Contact, 212-639-7592

    Deaglan McHugh

    Recruiting

  • Hi-Line Sletten Cancer Center

    Havre, Montana, 59501

    Suspended

  • Benefis Helena Specialty Center

    Helena, Montana, 59601

    Suspended

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Omid Yazdanpanah

    Recruiting

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

    Site Public Contact, 877-467-3411

    Charles B. Nguyen

    Recruiting

  • Allegiance Health

    Jackson, Michigan, 49201

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Clara Hwang

    Recruiting

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

    Suspended

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Logan Health Medical Center

    Kalispell, Montana, 59901

    Suspended

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

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

    Yu-Wei Chen

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Site Public Contact, 310-423-2133, Cancer.trial.info@cshs.org

    Edwin M. Posadas

    Recruiting

  • Covenant Medical Center-Lakeside

    Lubbock, Texas, 79410

    Site Public Contact, 806-725-8000, jaccresearch@covhs.org

    Gabriel Axelrud

    Recruiting

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

    Suspended

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

    Suspended

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

    Suspended

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

    Site Public Contact, 515-956-4132

    Joseph J. Merchant

    Recruiting

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

    Site Public Contact, 262-257-5100

    Kathryn A. Bylow

    Recruiting

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

    Site Public Contact, 212-639-7592

    Deaglan McHugh

    Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

    Site Public Contact, 414-805-3666

    Kathryn A. Bylow

    Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

    Suspended

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

    Suspended

  • Community Medical Center

    Missoula, Montana, 59804

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

    John M. Schallenkamp

    Recruiting

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

    Site Public Contact, 212-639-7592

    Deaglan McHugh

    Recruiting

  • SSM Health Good Samaritan

    Mount Vernon, Illinois, 62864

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

    Jay W. Carlson

    Recruiting

  • Froedtert and MCW Moorland Reserve Health Center

    New Berlin, Wisconsin, 53151

    Site Public Contact, 414-805-0505

    Kathryn A. Bylow

    Recruiting

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

    Suspended

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

    Suspended

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Site Public Contact, 212-639-7592

    Deaglan McHugh

    Recruiting

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

    Site Public Contact, 302-623-4450, lbarone@christianacare.org

    Gregory A. Masters

    Recruiting

  • CTCA at Southeastern Regional Medical Center

    Newnan, Georgia, 30265

    Site Public Contact, 770-400-6629

    Bamidele A. Adesunloye

    Recruiting

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

    Site Public Contact, 616-391-1230

    Kathleen Y. Butler

    Recruiting

  • Henry Ford Medical Center-Columbus

    Novi, Michigan, 48377

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Clara Hwang

    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

  • Northwestern Medicine Oak Brook

    Oak Brook, Illinois, 60523

    Site Public Contact, nctnprogram_rhlccc@northwestern.edu

    Michael Liu

    Recruiting

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

    Site Public Contact, 414-805-0505

    Kathryn A. Bylow

    Recruiting

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

    Suspended

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

    Site Public Contact, 877-827-8839, ucstudy@uci.edu

    Omid Yazdanpanah

    Recruiting

  • UI Healthcare Mission Cancer and Blood - Pella

    Pella, Iowa, 50219

    Suspended

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

    Site Public Contact, 609-394-4130, clinicaltrials@capitalhealth.org

    Nikhil Thaker

    Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

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

    Samir Narayan

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, 97213

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Natasha C. Edwin

    Recruiting

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

    Site Public Contact, 503-215-2614, CanRsrchStudies@providence.org

    Natasha C. Edwin

    Recruiting

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

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

    John M. Schallenkamp

    Recruiting

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

    Suspended

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

    Suspended

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

    Site Public Contact, 916-734-3089

    Lorenzo Nardo

    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

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

    Site Public Contact, 816-271-7937, Trisha.England2@mymlc.com

    Jay W. Carlson

    Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

    Suspended

  • Regions Hospital

    Saint Paul, Minnesota, 55101

    Suspended

  • United Hospital

    Saint Paul, Minnesota, 55102

    Suspended

  • UC San Diego Medical Center - Hillcrest

    San Diego, California, 92103

    Site Public Contact, rhabbaba@health.ucsd.edu

    Yu-Wei Chen

    Recruiting

  • Kootenai Clinic Cancer Services - Sandpoint

    Sandpoint, Idaho, 83864

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

    John M. Schallenkamp

    Recruiting

  • Swedish Medical Center-First Hill

    Seattle, Washington, 98122

    Suspended

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

    Suspended

  • 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

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

    Site Public Contact, 314-996-5569

    Bryan A. Faller

    Recruiting

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

    Suspended

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Benjamin A. Gartrell

    Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

    Site Public Contact, 718-379-6866, eskwak@montefiore.org

    Benjamin A. Gartrell

    Recruiting

  • Munson Medical Center

    Traverse City, Michigan, 49684

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553

    Site Public Contact, 212-639-7592

    Deaglan McHugh

    Recruiting

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

    Suspended

  • Northwestern Medicine Cancer Center Warrenville

    Warrenville, Illinois, 60555

    Site Public Contact, 630-352-5360, Donald.Smith3@nm.org

    Michael Liu

    Recruiting

  • UI Health Care Mission Cancer and Blood - Waukee Clinic

    Waukee, Iowa, 50263

    Suspended

  • Froedtert West Bend Hospital/Kraemer Cancer Center

    West Bend, Wisconsin, 53095

    Site Public Contact, 414-805-0505

    Kathryn A. Bylow

    Recruiting

  • Henry Ford West Bloomfield Hospital

    West Bloomfield, Michigan, 48322

    Site Public Contact, 313-916-3721, CTOResearch@hfhs.org

    Clara Hwang

    Recruiting

  • The Iowa Clinic PC

    West Des Moines, Iowa, 50266

    Suspended

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

    Suspended

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

    Suspended

  • Henry Ford Wyandotte Hospital

    Wyandotte, Michigan, 48192

    Site Public Contact, nhay@hfhs.org

    Clara Hwang

    Recruiting

  • University of Michigan Health - West

    Wyoming, Michigan, 49519

    Site Public Contact, 616-391-1230, crcwm-regulatory@crcwm.org

    Kathleen Y. Butler

    Recruiting

  • Fairview Lakes Medical Center

    Wyoming, Minnesota, 55092

    Suspended

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

    Site Public Contact, 844-793-0745

    Walter M. Stadler

    Recruiting

Other trials in United States

About this study

Official title: Radioligand Efficacy Comparison by Initial PSA-Response Outcome in Metastatic CRPC With Lutetium 177Lu PSMA RLT (RECIPROCAL)

This randomized phase III trial examines whether lengthening the dosage interval in an adaptive manner for the prostate cancer drug lutetium 177 Lu PSMA RLT improves quality of life without decreasing lifespan when compared to the standard way this medication is given. This study is for patients with hormone resistant prostate cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body. Hormone resistant prostate cancer often has many cells containing a protein called prostate-specific membrane antigen (PSMA) on their surface. The normal cells in the prostate do not normally express as much PSMA protein on their surface as cancer cells. Lutetium 177 Lu PSMA RLT binds to the PSMA protein on the tumor cells. It builds up in these cells and gives off radiation that may kill them. Typically, this medication is given at the same dose every 6 weeks for up to 6 doses. In this trial, researchers want to see if treatment following the first two doses of lutetium 177 Lu PSMA RLT can be delayed until there is evidence of disease activity. This may be an effective way to improve quality of life without decreasing lifespan in patients with advanced prostate cancer.

Read the detailed description

The primary and secondary objectives of the study:

PRIMARY OBJECTIVES:

  1. To compare the overall survival (OS) of patients with metastatic castration-resistant prostate carcinoma (mCRPC) receiving prostate-specific antigen (PSA) adaptive dosing of lutetium 177 Lu prostate specific membrane antigen radioligand therapy (177Lu PSMA RLT) to that of patients receiving standard dose 177Lu PSMA RLT every 6 weeks.

II. To compare quality of life, as measured by Functional Assessment of Cancer Therapy- Prostate (FACT-P) total scores averaged across the first 30 months, in patients with mCRPC who receive 177Lu PSMA RLT adaptive dosing versus standard dosing.

SECONDARY OBJECTIVES:

  1. To compare the duration of treatment between standard dosing and adaptive dosing.

II. To compare the radiographic progression-free survival (rPFS) between the treatment arms.

III. To evaluate and compare the toxicity profile of 177Lu PSMA RLT standard dosing and 177Lu PSMA RLT adaptive dosing.

IV. To compare the nadir PSA and PSA kinetics between standard and adaptive dosing.

  1. To compare quality-adjusted life years, which accounts for overall survival and health utility (measured by European Quality of Life Five Dimension Five Level Scale [EQ-5D-5L]), between arms.

VI. To compare pain severity, as measured by the Brief Pain Inventory - Short Form (BPI-SF), between arms at 12 and 30 months.

EXPLORATORY OBJECTIVES:

  1. To determine the frequency of tumor genomic aberrations (including but not limited to androgen receptor [AR] mutation/amplification, deoxyribonucleic acid [DNA] repair, retinoblastoma 1 [RB1], phosphatase and tensin homolog [PTEN], TP53) by circulating-tumor deoxyribonucleic acid (ctDNA) in patients achieving > 50% PSA decline versus (vs) < 50% PSA decline after 2 cycles of 177Lu PSMA RLT.

II. To evaluate the relationship between OS and initial PSA response (e.g. ≥ 50% decline in PSA level from baseline [PSA50] vs ≥ 75% decline in PSA level from baseline [PSA75] vs ≥ 90% decline in PSA level from baseline [PSA90]) prior to randomization.

OUTLINE:

PRE-REGISTRATION STEP 0: Patients receive 177Lu PSMA RLT intravenously (IV) on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PSA50 response at cycle (C) 2 day (D) 22 proceed to Step 1.

RANDOMIZATION STEP 1: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.

ARM 2: Starting cycle 2 day 42, patients undergo blood sample collection and PSA monitoring once every 3 weeks (Q3W) in the absence of disease progression or unacceptable toxicity. Patients with either an absolute PSA rise > 4 ng/dL, PSA rise > 25% above nadir, or clinical progression receive 177Lu PSMA RLT IV three weeks later. Patients then resume PSA monitoring Q3W with adaptive 177Lu PSMA RLT dosing for up to 4 total doses in the absence of disease progression or unacceptable toxicity.

Additionally, all patients undergo blood sample collection, computed tomography (CT), and bone scan throughout the trial and PSMA positron emission tomography (PET) during screening. Patients with a history of brain metastases or with clinical indication also undergo magnetic resonance imaging (MRI) throughout the trial.

After completion of study treatment, patients are followed up every 12 weeks until disease progression and then every 6 months thereafter for 5 years following registration.

Being tested
Lutetium Lu 177 Vipivotide Tetraxetan, Biospecimen Collection, Patient Monitoring, Computed Tomography, Bone Scan
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Lutetium Lu 177 Vipivotide TetraxetanDrug

    Also called Pluvicto

    Given IV

  • Biospecimen CollectionProcedure or surgery

    Undergo blood sample collection

  • Patient MonitoringProcedure or surgery

    Undergo PSA monitoring

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, CT Scan

    Undergo CT

  • Bone ScanProcedure or surgery

    Undergo Bone Scan

  • PSMA PET ScanProcedure or surgery

    Undergo PSMA PET Scan

  • MRIProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging

    Undergo MRI

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT07200830
Study groupRoleWhat they receive
Pre-registration step 0 (177Lu PSMA RLT)Active comparatorPatients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve a PSA50 response at C2 D22 proceed to Step 1. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial.
Receives: Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: MRI; Other: Questionnaire Administration
Randomization step 1 arm 1 (standard dose 177Lu PSMA RLT)Active comparatorPatients receive 177Lu PSMA RLT IV on day 1 of each cycle. Cycles repeat every 6 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial
Receives: Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: MRI; Other: Questionnaire Administration
Randomization step 1 arm 2 (adaptive dose 177Lu PSMA RLT )ExperimentalStarting cycle 2 day 42, patients undergo blood sample collection and PSA monitoring Q3W in the absence of disease progression or unacceptable toxicity. Patients with either an absolute PSA rise > 4 ng/dL, PSA rise > 25% above nadir, or clinical progression receive 177Lu PSMA RLT IV three weeks later. Patients then resume PSA monitoring Q3W with adaptive 177Lu PSMA RLT dosing as above for up to 4 total doses in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, and bone scan throughout the trial and PSMA PET during screening. Patients with a history of brain metastases or with clinical indication also undergo MRI throughout the trial.
Receives: Drug: Lutetium Lu 177 Vipivotide Tetraxetan; Procedure: Biospecimen Collection; Procedure: Patient Monitoring; Procedure: Computed Tomography; Procedure: Bone Scan; Procedure: PSMA PET Scan; Procedure: MRI; 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 be calculated as time from randomization until death due to any cause, censoring patients not known to have died at the time of their last follow-up. OS will be compared between the treatment arms using a stratified log rank test

    Measured: Up to 5 years

  2. Quality of life

    Will be measured using the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total scores. A repeated measures mixed model will be used to evaluate the between-arm mean difference in FACT-P Total scores across the first 30 months from treatment start. A point estimate of the difference and 95% confidence interval will be reported. Results of formal hypothesis testing will only be reported if adaptive dosing is deemed noninferior to standard dosing with regards to overall survival.

    Measured: Up to 30 months

Secondary outcomes (7)

  1. Duration of treatment

    Calculated from the first administration of 177Lu PSMA RLT to the last administration of 177Lu PSMA RLT among randomized patients. Summary measures for the duration of treatment will be recorded by arm and the stratified Wilcoxon rank sum statistic will be used to test whether the treatment duration distribution differs between the standard and adaptive dose treatments.

    Measured: Up to 5 years

  2. Radiographic progression-free survival (rPFS)

    Will be defined as time from randomization to the to the date of radiographic disease progression per the Prostate Cancer Clinical Trials Working Group 3 criteria or death from any cause, whichever occurs first. Patients who are alive without a disease progression will be censored at the time of their last disease evaluation. rPFS will be compared between the two treatment arms using a stratified logrank test.

    Measured: Up to 5 years

  3. Rate of Grade 3+ AEs

    Will be assessed using Common Terminology Criteria for Adverse Events version 5.0. The proportion of patients that experience a grade 3+ AE regardless of attribution will be summarized as the number and percent of patients by treatment arm.

    Measured: Up to 5 years

  4. Prostate-specific antigen (PSA) response

    There will be different thresholds used for PSA response, all measured as change from baseline and confirmed at least 3 weeks later by a second PSA test: PSA50 (a ≥ 50% decline), PSA75 (a ≥ 75% decline), and PSA90 (a ≥ 90% decline).

    Measured: Prior to randomization

  5. Nadir PSA

    This is the lowest PSA value observed starting from baseline.

    Measured: Up to 5 years

  6. Pain Severity

    This will be measured using the Brief Pain Index Short Form (BPI-SF). Estimates and 95% confidence intervals for the mean difference between treatment arms at 12 and 30 months will be generated using a repeated measures mixed model.

    Measured: Up to 30 months

  7. Quality-adjusted life years

    This will be calculated from overall survival and health utility as measured by European Quality of Life Five Dimension Five Level Scale (EQ-5D-5L) using an area under the curve approach. Summary statistics for the area under the curve of each arm and a 95% CI for the difference between arms will be reported.

    Measured: Up to 5 years

Timeline

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

  1. First posted1 Oct 2025
  2. Study start31 Mar 2026
  3. Primary completion9 Sep 2034 (estimated)
  4. Study completion9 Sep 2034 (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
1,524 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200830
Sponsor's protocol ID
A032304
Other IDs
NCI-2025-06146
Status last verified
Oct 2026
First submitted
23 Sep 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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