AzTrials
AzTrials

Castration-Sensitive Prostate CarcinomaPhase 2A-DREAMNCT05241860

Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)

A Phase 2 study testing Pharmacotherapy Discontinuation, Follow-Up and Questionnaire Administration in people with Castration-Sensitive Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 326 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Pharmacotherapy Discontinuation, Follow-Up and Questionnaire Administration
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
326 sitesUnited States
Study dates
21 Nov 2022to 1 Sep 2033
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Histologic or clinical diagnosis of metastatic prostate cancer
  • Must have had evidence of metastatic disease by bone scan; or bone, nodal or visceral lesions on CT or MRI prior to starting on intense antiandrogen therapy (ADT)
  • If only positron emission tomography (PET) imaging was performed prior to starting on intense ADT, then there must have been evidence of metastatic disease on the CT/MRI component (i.e. sclerotic bone lesion, non-regional lymph node >= 15 mm, and/or soft tissue lesion >= 10 mm).
  • Radiographic evidence of disease is not required at the time of enrollment
  • No metastases to liver or to brain, as these represent aggressive variant disease biology for which intermittent treatment may not be favored
  • Must currently be receiving intense ADT for metastatic hormone sensitive prostate cancer (mHSPC)
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  • Testosterone suppression (TS) with luteinizing hormone releasing hormone (LHRH)-agonist or LHRH-antagonist AND
  • An approved secondary androgen receptor pathway inhibitor (ARPI) abiraterone, enzalutamide, apalutamide or darolutamide)
  • Must have remained on testosterone suppression for metastatic disease continuously (without treatment breaks) for 540-750 days (approximately 18 to 24 months) from time of first dose of LHRH agonist or antagonist by time of registration. A period of anti-androgen treatment prior to LHRH agonist or antagonist initiation is not included in the 540 - 750 days (approximately 18 to 24 months)
  • Must have received treatment with ARPI for at least 360 days in total by time of A032101 registration. Treatment breaks from the ARPI of up to 60 days are permitted (for example peri-procedural or for management of a temporary adverse event or lapse in financial coverage) as long as PSA did not rise while holding therapy and the patient has resumed for at least 30 days (without a dose hold > 72 hours within those 30 days) by time of registration. A break from ARPI longer than 60 days is permitted if a patient needed to discontinue a different ARPI for toxicity, as long as PSA did not rise while holding therapy and the patient has received at least 360 days of ARPI in total.
  • Prior TS in the context of neoadjuvant/concurrent/adjuvant treatment with local therapy is permitted. Prior course(s) of intermittent TS for biochemical-only recurrence is permitted. However, if the patient previously received TS, metastatic progression for which intense ADT was initiated must have occurred during an off-treatment interval and with testosterone >= 150 ng/dL
  • Prior local therapy for prostate cancer (either before or after diagnosis of metastatic disease) is permitted. Prior treatment with docetaxel chemotherapy for up to 6 cycles is permitted. Prior radiation therapy to metastatic sites (either for symptom palliation or for ablation of oligometastatic disease) is permitted

Who cannot join

  • No history of surgical castration
  • No history of ARPI use prior to diagnosis of mHSPC for which the patient is currently receiving intense ADT (such as in the neoadjuvant setting with prior local therapy)
  • No current or prior treatment with experimental agents for metastatic hormone-sensitive prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Prior to initiating intense ADT
  • PSA >= 5 ng/ml (does not need to be the most recent value prior to enrollment)
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  • Testosterone >= 150 ng/dl. Patients are permitted to enroll if testosterone was not measured prior to initiating intense ADT for mHSPC if they did not previously receive TS and were not known or suspected to be hypogonadal at the time
  • At time of enrollment to A032101
  • PSA < 0.2 ng/ml
  • PSA values (measured in the same laboratory) must be stable or falling for 3 consecutive measurements - i.e. any PSA rise must be followed by a decrease in PSA that is further decreased or stable on a 3rd measurement. Any patient with 2 consecutive rises in PSA values since achieving castrate level of testosterone is not eligible
  • Testosterone < 50 ng/dl
  • No current participation in a clinical study that does not allow for TS or ARPI interruption
  • No patients with a "currently active" second malignancy * Patients with non-melanomatous skin cancer, superficial bladder cancer, cancer not needing active therapy for at least 2 years, cancer for which the treating investigator deems the subject

Trial locations and contacts

326 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Mission Hope Medical Oncology - Arroyo Grande

    Arroyo Grande, California, 93420

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • UM Sylvester Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • Saint Alphonsus Medical Center-Baker City

    Baker City, Oregon, 97814

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Elizabeth Boardman Hospital

    Boardman, Ohio, 44512

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • McFarland Clinic - Boone

    Boone, Iowa, 50036

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Saint Joseph Mercy Brighton

    Brighton, Michigan, 48114

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • University of Michigan - Brighton Center for Specialty Care

    Brighton, Michigan, 48116

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cambridge Medical Center

    Cambridge, Minnesota, 55008

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Joseph Mercy Canton

    Canton, Michigan, 48188

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • Mercy Cancer Center �� Carmichael

    Carmichael, California, 95608

  • Mercy San Juan Medical Center

    Carmichael, California, 95608

  • Caro Cancer Center

    Caro, Michigan, 48723

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Saint Mary's Hospital

    Centralia, Illinois, 62801

  • Saint Joseph Mercy Chelsea

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Health - Coeur d'Alene

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • Saint Francis Cancer Center

    Colorado Springs, Colorado, 80923

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • Dayton Blood and Cancer Center

    Dayton, Ohio, 45409

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC-Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Northwestern Medicine Cancer Center Kishwaukee

    DeKalb, Illinois, 60115

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Mission Cancer and Blood - Laurel

    Des Moines, Iowa, 50314

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Illinois CancerCare-Dixon

    Dixon, Illinois, 61021

  • Epic Care-Dublin

    Dublin, California, 94568

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Great Lakes Cancer Management Specialists-Doctors Park

    East China, Michigan, 48054

  • Pocono Medical Center

    East Stroudsburg, Pennsylvania, 18301

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Mercy Cancer Center - Elk Grove

    Elk Grove, California, 95758

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Walter Knox Memorial Hospital

    Emmett, Idaho, 83617

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Sanford South University Medical Center

    Fargo, North Dakota, 58103

  • Southpointe-Sanford Medical Center Fargo

    Fargo, North Dakota, 58103

  • Sanford Medical Center Fargo

    Fargo, North Dakota, 58104

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McFarland Clinic - Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas, 72903

  • Dana-Farber Cancer Institute at Foxborough

    Foxborough, Massachusetts, 02035

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Central Care Cancer Center - Garden City

    Garden City, Kansas, 67846

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Academic Hematology Oncology Specialists

    Grosse Pointe Woods, Michigan, 48236

  • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

    Grosse Pointe Woods, Michigan, 48236

  • Michigan Breast Specialists-Grosse Pointe Woods

    Grosse Pointe Woods, Michigan, 48236

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Lehigh Valley Hospital-Hazleton

    Hazleton, Pennsylvania, 18201

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • McFarland Clinic - Jefferson

    Jefferson, Iowa, 50129

  • Capital Region Southwest Campus

    Jefferson City, Missouri, 65109

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Monmouth Medical Center Southern Campus

    Lakewood, New Jersey, 08701

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • Saint Joseph Hospital

    Lexington, Kentucky, 40504

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Saint Joseph London

    London, Kentucky, 40741

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Longmont United Hospital

    Longmont, Colorado, 80501

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Great Lakes Cancer Management Specialists-Macomb Medical Campus

    Macomb, Michigan, 48044

  • Michigan Breast Specialists-Macomb Township

    Macomb, Michigan, 48044

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • McFarland Clinic - Marshalltown

    Marshalltown, Iowa, 50158

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Sovah Health Martinsville

    Martinsville, Virginia, 24115

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • Mercy UC Davis Cancer Center

    Merced, California, 95340

  • Idaho Urologic Institute-Meridian

    Meridian, Idaho, 83642

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Garnet Health Medical Center

    Middletown, New York, 10940

  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

    Milford, Massachusetts, 01757

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Toledo Clinic Cancer Centers-Monroe

    Monroe, Michigan, 48162

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645

  • Saint Joseph Mount Sterling

    Mount Sterling, Kentucky, 40353

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

  • UC Comprehensive Cancer Center at Silver Cross

    New Lenox, Illinois, 60451

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Saint Alphonsus Medical Center-Ontario

    Ontario, Oregon, 97914

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Northwestern Medicine Orland Park

    Orland Park, Illinois, 60462

  • University of Chicago Medicine-Orland Park

    Orland Park, Illinois, 60462

  • Lake Regional Hospital

    Osage Beach, Missouri, 65065

  • Upstate Cancer Center at Oswego

    Oswego, New York, 13126

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Midlands Community Hospital

    Papillion, Nebraska, 68046

  • Parker Adventist Hospital

    Parker, Colorado, 80138

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • OSF Saint Francis Radiation Oncology at Peoria Cancer Center

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Jefferson Methodist Hospital

    Philadelphia, Pennsylvania, 19148

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

  • 21st Century Oncology-Pontiac

    Pontiac, Michigan, 48341

  • Hope Cancer Center

    Pontiac, Michigan, 48341

  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Kootenai Clinic Cancer Services - Post Falls

    Post Falls, Idaho, 83854

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Fairview Northland Medical Center

    Princeton, Minnesota, 55371

  • Saint Mary Corwin Medical Center

    Pueblo, Colorado, 81004

  • Eisenhower Medical Center

    Rancho Mirage, California, 92270

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Reid Health

    Richmond, Indiana, 47374

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mercy Cancer Center - Rocklin

    Rocklin, California, 95765

  • Delbert Day Cancer Institute at PCRMC

    Rolla, Missouri, 65401

  • Mercy Clinic-Rolla-Cancer and Hematology

    Rolla, Missouri, 65401

  • Mercy Cancer Center - Sacramento

    Sacramento, California, 95816

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Sainte Genevieve County Memorial Hospital

    Sainte Genevieve, Missouri, 63670

  • Pacific Central Coast Health Center-San Luis Obispo

    San Luis Obispo, California, 93401

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Mission Hope Medical Oncology - Santa Maria

    Santa Maria, California, 93444

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Welch Cancer Center

    Sheridan, Wyoming, 82801

  • Memorial Hospital East

    Shiloh, Illinois, 62269

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Sanford USD Medical Center - Sioux Falls

    Sioux Falls, South Dakota, 57117-5134

  • Dana-Farber/Brigham and Women's Cancer Center at South Shore

    South Weymouth, Massachusetts, 02190

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62702

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Saint Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Mercy Hospital South

    St Louis, Missouri, 63128

  • Siteman Cancer Center-South County

    St Louis, Missouri, 63129

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Siteman Cancer Center at Christian Hospital

    St Louis, Missouri, 63136

  • Mercy Hospital Saint Louis

    St Louis, Missouri, 63141

  • Bhadresh Nayak MD PC-Sterling Heights

    Sterling Heights, Michigan, 48312

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin, 54482

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Missouri Baptist Sullivan Hospital

    Sullivan, Missouri, 63080

  • BJC Outpatient Center at Sunset Hills

    Sunset Hills, Missouri, 63127

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • SUNY Upstate Medical Center-Community Campus

    Syracuse, New York, 13215

  • Franciscan Research Center-Northwest Medical Plaza

    Tacoma, Washington, 98405

  • Ascension Saint Joseph Hospital

    Tawas City, Michigan, 48764

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center-Weiler Hospital

    The Bronx, New York, 10461

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, 10467

  • Sanford Thief River Falls Medical Center

    Thief River Falls, Minnesota, 56701

  • Toledo Clinic Cancer Centers-Toledo

    Toledo, Ohio, 43623

  • Community Medical Center

    Toms River, New Jersey, 08755

  • Dayton Physicians LLC - Troy

    Troy, Ohio, 45373

  • Upper Valley Medical Center

    Troy, Ohio, 45373

Other trials in United States

About this study

Official title: A Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer (MHSPC): A-DREAM

This phase II trial examines antiandrogen therapy interruptions in patients with hormone-sensitive prostate cancer that has spread to other places in the body (metastatic) responding exceptionally well to androgen receptor-pathway inhibitor therapy. The usual treatment for patients with metastatic prostate cancer is to receive hormonal medications including a medication to decrease testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones (like testosterone) in the cancer cells. Patients whose cancer is responding exceptionally well to this therapy may take a break from these medications according to their doctor's guidance. This trial may help doctors determine if stopping treatment can allow for testosterone recovery.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To determine the proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption.

SECONDARY OBJECTIVES:

  1. To determine time to eugonadal testosterone (> 150 ng/dl). II. To determine duration off-treatment.

III. To assess changes in quality of life as follows:

  1. To assess changes in patient-reported quality of life as assessed by the Functional Assessment of Cancer Therapy- Prostate (FACT-P) total score from baseline to 24 months after treatment interruption.
  2. To assess changes in the FACT-P subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to 24 months after treatment interruption.
  3. To assess changes in the FACT-P total score and subscales (i.e., physical well-being, social and family well-being, emotional well-being, functional well-being, and prostate cancer subscale) from baseline to the remaining post-baseline time points (i.e., 6, 12, and 18 months) after treatment interruption.

OUTLINE:

Patients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in prostate specific antigen (PSA) level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments.

After completion of study treatment, patients are followed up every 6 months for 10 years from registration or withdrawal from the study or death.

Being tested
Pharmacotherapy Discontinuation, Follow-Up, Questionnaire Administration, Quality-of-Life Assessment
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • Pharmacotherapy DiscontinuationOther

    Also called Medication Discontinuation

    Stop hormonal medications (Abiraterone, Enzalutamide, Apalutamide, Leuprolide, Goserelin, Degarelix, Relugolix)

  • Follow-UpOther

    Undergo follow-up

  • Questionnaire AdministrationOther

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Ancillary studies

Study groups in NCT05241860
Study groupRoleWhat they receive
Treatment (discontinue hormonal medication, follow up)ExperimentalPatients stop both hormonal medications (medication to decrease testosterone levels in the body and potent oral hormonal medication to block growth signals from male hormones in the cancer cells). Patients are then followed every 12 months for symptoms. Patients with an increase in PSA level to greater than or equal to 5 ng/ml, changes on imaging studies suggesting that their cancer is growing back, or symptoms that the doctor thinks is related to their cancer growing back, resume both hormonal treatments. Patients undergo CT scans, MRI scans and bone scans prior to registration and throughout study. Patients may optionally undergo biopsies and additional collection of blood on study.
Receives: Other: Pharmacotherapy Discontinuation; Other: Follow-Up; Other: Questionnaire Administration; Other: Quality-of-Life Assessment

What is being measured

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

  1. Treatment-free With Eugonadal Testosterone (>= 150 ng/dl)

    The proportion of men who experience 18-month treatment-free interval from therapy with eugonadal testosterone (to >= 150 ng/ml) after treatment interruption will be calculated for the study cohort.

    Measured: At 18 months

Secondary outcomes (8)

  1. Time to Eugonadal Testosterone

    The median time to eugonadal testosterone (> 150 ng/dl) will be computed by the cumulative incidence function.

    Measured: Up to 10 years

  2. Duration Off-treatment

    The median time off-treatment.

    Measured: Up to 10 years

  3. Radiographic Progression-free Survival

    The median time to radiographic progression or death (whichever occurs first) will be computed by the Kaplan-Meier estimator.

    Measured: Up to 10 years

  4. Time to Next Treatment

    The median time to the first subsequent treatment will be computed by the cumulative incidence function.

    Measured: Up to 24 months

  5. Overall Survival

    The median survival time will be computed by the Kaplan-Meier estimator. Survival time defined as from treatment interruption per protocol to death due to any cause or censored at date last known alive.

    Measured: Assessed up to 10 years

  6. Cancer-specific Survival

    The median survival time will be computed by the cumulative incidence function. Cancer-specific survival as defined as from treatment interruption per protocol to death attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive.

    Measured: Assessed up to 10 years

  7. Non-cancer Specific Survival

    The median survival time will be computed by the cumulative incidence function. Non-cancer-specific survival as defined as from treatment interruption per protocol to death not attributable to cancer or its treatment in the opinion of the treating investigator or censored at date last known alive.

    Measured: Up to 10 years

  8. Prostate Specific Antigen (PSA) Progression-free Survival

    The median PSA progression free survival time will be computed by the Kaplan-Meier estimator. PSA progression free survival as defined as from treatment interruption per protocol to the first PSA failure (two consecutive increases in PSA of 25% and >= 2 ng/mL above nadir) or death.

    Measured: Assessed 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 posted16 Feb 2022
  2. Study start21 Nov 2022
  3. Primary completion29 Sep 2025
  4. Study completion1 Sep 2033 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05241860
Sponsor's protocol ID
A032101
Other IDs
U10CA180821, NCI-2021-13974
Acronym
A-DREAM
Status last verified
Aug 2026
First submitted
31 Jan 2022
Last updated
24 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pharmacotherapy Discontinuation, Follow-Up and Questionnaire Administration in people with Castration-Sensitive Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, run by Alliance for Clinical Trials in Oncology at 326 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 12 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 326 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-free With Eugonadal Testosterone (>= 150 ng/dl) (time frame: At 18 months). 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 NCT05241860.

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 24 Sep 2026.

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