New drug combo aims to block prostate cancer return in High-Risk men

NCT ID NCT04484818

Disease control Sponsor: ECOG-ACRIN Cancer Research Group Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 5 times

Summary

This phase 3 trial tests whether adding darolutamide to standard hormone therapy (ADT) after prostate removal surgery can better prevent cancer from spreading in men with high-risk prostate cancer. The study enrolls 27 men who had their prostate removed and are at highest risk of metastasis based on genetic tests. Participants receive either darolutamide plus ADT or a placebo plus ADT, and researchers track how long they remain cancer-free.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Darolutamide (a drug that blocks testosterone's effects on cancer cells) plus androgen deprivation therapy (ADT, which lowers testosterone levels)
What this could lead to: If successful, this combination could help prevent prostate cancer from spreading (metastasizing) after surgery in men at highest risk.
What could go wrong: This is a small early-phase trial with only 27 participants, so results may not apply to all patients. Adding darolutamide may cause additional side effects like fatigue or high blood pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

27 people

The number who actually took part.

Started

Mar 2021

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * PRE-REGISTRATION INCLUSION (STEP 0) * Patient must have undergone a radical prostatectomy (RP) and must be registered to step 0 of this study at least 6 weeks after but not more than 16 weeks after their radical prostatectomy * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2 * Patient with a prior or concurrent malignancy within 5 years of registration, 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 * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * 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 * For patients with no previous Decipher score: Tumor tissue specimen from prostatectomy must be available and ready to be shipped * INCLUSION CRITERIA FOR RANDOMIZATION (STEP 1) * For patients who have previously had Decipher score performed by Decipher Biosciences, they must have score of \>= 0.6 * For patients who did not have a Decipher score previously performed by Decipher Biosciences, they must have had a Decipher score of \>= 0.6 assessed from the prostatectomy specimen submitted * For patients who did not have a Decipher score previously performed by Decipher Biosciences, patients must also have a CAPRA-S score \>= 3. The CAPRA-S score is calculated by assigning points for PSA in ng/mL, surgical margin status, seminal vesicle invasion, and extra-capsular extension. Lymph node involvement will serve as an exclusion criteria and will not count towards CAPRA-S inclusion score. A CAPRA-S score is not required for patients who had a Decipher score previously performed by Decipher Biosciences * Patient must have an undetectable PSA (\< 0.2ng/mL) obtained within 2 weeks prior to randomization * Leukocytes \>= 3,000/mcL (obtained within 4 weeks prior to registration) * Absolute neutrophil count \>= 1,000/mcL (obtained within 4 weeks prior to registration) * Platelets \>= 75,000/mcL (obtained within 4 weeks prior to registration) * Total bilirubin =\< institutional upper limit of normal (ULN) (obtained within 4 weeks prior to registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (obtained within 4 weeks prior to registration) * Glomerular filtration rate (GFR) \>= 30 mL/min/1.73 m\^2 (obtained within 4 weeks prior to registration) Exclusion Criteria: * PRE-REGISTRATION EXCLUSION (STEP 0) * Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer * Patient must not have pathologic evidence of pelvic lymph node involvement * Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association class III and IV heart failure), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * EXCLUSION CRITERIA FOR RANDOMIZATION (STEP 1) * Patient must not have pre or post-operative radiographic evidence of cancer recurrence or metastasis by abdominal and pelvic imaging (computed tomography \[CT\] abdomen/pelvis, whole body magnetic resonance imaging \[MRI\], MRI abdomen/pelvis, or equivalent, AND bone scan) which must be done before or after prostatectomy prior to randomization. If pre-operative risk does not indicate a need for bone scan, post-operative Decipher score of \>= 0.6 indicates increased risk of metastatic disease and may be used to obtain CT abdomen/pelvis and bone scan prior to randomization

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate carcinoma

Contacts and locations

Locations

Addison Gilbert Hospital

Gloucester, Massachusetts, 01930, United States
Audie L Murphy VA Hospital

San Antonio, Texas, 78229, United States
Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405, United States
Beverly Hospital

Beverly, Massachusetts, 01915, United States
Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States
Broadlawns Medical Center

Des Moines, Iowa, 50314, United States
Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526, United States
Carle Cancer Center

Urbana, Illinois, 61801, United States
Carle Physician Group-Effingham

Effingham, Illinois, 62401, United States
Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938, United States
Carle on Vermilion

Danville, Illinois, 61832, United States
City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States
City of Hope South Pasadena

South Pasadena, California, 91030, United States
City of Hope Upland

Upland, California, 91786, United States
Crossroads Cancer Center

Effingham, Illinois, 62401, United States
Decatur Memorial Hospital

Decatur, Illinois, 62526, United States
Edward Hospital/Cancer Center

Naperville, Illinois, 60540, United States
Elmhurst Memorial Hospital

Elmhurst, Illinois, 60126, United States
Geisinger Medical Center

Danville, Pennsylvania, 17822, United States
Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711, United States
Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701, United States
GenesisCare USA - Clarkston

Clarkston, Michigan, 48346, United States
GenesisCare USA - Farmington Hills

Farmington Hills, Michigan, 48334, United States
GenesisCare USA - Lakewood Ranch

Lakewood Rch, Florida, 34202, United States
GenesisCare USA - Macomb

Macomb, Michigan, 48044, United States
GenesisCare USA - Madison Heights

Madison Heights, Michigan, 48071, United States
GenesisCare USA - Plantation

Plantation, Florida, 33324, United States
GenesisCare USA - Troy

Troy, Michigan, 48098, United States
Hartford Hospital

Hartford, Connecticut, 06102, United States
Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States
Illinois CancerCare - Washington

Washington, Illinois, 61571, United States
Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton

Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage

Carthage, Illinois, 62321, United States
Illinois CancerCare-Eureka

Eureka, Illinois, 61530, United States
Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401, United States
Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443, United States
Illinois CancerCare-Macomb

Macomb, Illinois, 61455, United States
Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin

Pekin, Illinois, 61554, United States
Illinois CancerCare-Peoria

Peoria, Illinois, 61615, United States
Illinois CancerCare-Peru

Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton

Princeton, Illinois, 61356, United States
Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States
Iowa Lutheran Hospital

Des Moines, Iowa, 50316, United States
Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States
Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States
Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States
Lahey Medical Center-Peabody

Peabody, Massachusetts, 01960, United States
Los Angeles County-USC Medical Center

Los Angeles, California, 90033, United States
Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548, United States
Marshfield Medical Center - Weston

Weston, Wisconsin, 54476, United States
Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701, United States
Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868, United States
Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482, United States
Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, 50325, United States
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Memorial Medical Center

Springfield, Illinois, 62781, United States
Mercy Hospital Saint Louis

St Louis, Missouri, 63141, United States
Methodist Medical Center of Illinois

Peoria, Illinois, 61636, United States
Methodist West Hospital

West Des Moines, Iowa, 50266-7700, United States
Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109, United States
Mission Cancer and Blood - Laurel

Des Moines, Iowa, 50314, United States
Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States
Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States
New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, 03301, United States
NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, 60201, United States
NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, 60035, United States
Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045, United States
Northwestern University

Chicago, Illinois, 60611, United States
Pali Momi Medical Center

‘Aiea, Hawaii, 96701, United States
Parkland Memorial Hospital

Dallas, Texas, 75235, United States
Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States
Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States
Queen's Cancer Center - Kuakini

Honolulu, Hawaii, 96817, United States
Queen's Medical Center

Honolulu, Hawaii, 96813, United States
Ralph H Johnson VA Medical Center

Charleston, South Carolina, 29401, United States
Reading Hospital

West Reading, Pennsylvania, 19611, United States
Regions Hospital

Saint Paul, Minnesota, 55101, United States
Rush - Copley Medical Center

Aurora, Illinois, 60504, United States
Saint Francis Medical Center

Cape Girardeau, Missouri, 63703, United States
Sanford Bismarck Medical Center

Bismarck, North Dakota, 58501, United States
Sanford Broadway Medical Center

Fargo, North Dakota, 58122, United States
Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122, United States
Solinsky Center for Cancer Care

Manchester, New Hampshire, 03103, United States
Southern Illinois University School of Medicine

Springfield, Illinois, 62702, United States
Springfield Clinic

Springfield, Illinois, 62702, United States
Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304, United States
Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, 96817, United States
The Carle Foundation Hospital

Urbana, Illinois, 61801, United States
UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451, United States
USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States
UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, 75080, United States
UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, 76104, United States
Unity Hospital

Fridley, Minnesota, 55432, United States
University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States
University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219, United States
University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069, United States
University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States
University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
University of Toledo

Toledo, Ohio, 43614, United States
University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States
VA Palo Alto Health Care System

Palo Alto, California, 94304, United States
Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States
Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States
Wake Forest University at Clemmons

Clemmons, North Carolina, 27012, United States
William Beaumont Hospital - Troy

Troy, Michigan, 48085, United States
William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, 48073, United States
William S Middleton VA Medical Center

Madison, Wisconsin, 53705, United States
Winchester Hospital

Winchester, Massachusetts, 01890, United States

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