Prostate Cancer

EA8183 / ERADICATE



Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) after Surgery for Men with High-Risk Prostate Cancer, The ERADICATE Study

STATUS: Active


This phase III trial compares the effect of adding darolutamide to ADT versus ADT alone after surgery for the treatment of high-risk prostate cancer. ADT reduces testosterone levels in the blood. Testosterone is a hormone made mainly in the testes and is needed to develop and maintain male sex characteristics, such as facial hair, deep voice, and muscle growth. It also plays a role in prostate cancer development. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. Giving darolutamide with ADT may work better in eliminating or reducing the size of the cancer and / or prevent it from returning compared to ADT alone in patients with prostate cancer.
  • PRE-REGISTRATION INCLUSION (STEP 0)

  • Patient must be >= 18 years of age

  • Patient must have undergone a radical prostatectomy (RP) completed at least 2 weeks prior to Step 0 pre-registration. Patient must also meet one of the following criteria: * For patients with a Decipher score obtained through standard of care testing outside the protocol prior to registration to Step 0: ** The Decipher score must be > 0.6. ** The patient must be registered to Step 0 no later than 24 weeks (168 days) after surgery. ** The Decipher Score assay results and report must be available for upload to Medidata Rave prior to proceeding to Step 1 Randomization * For patients without a previous Decipher score performed through standard of care testing outside the protocol prior to registration to Step 0 ** The patient must be registered to Step 0 no later than 19 weeks (133 days) after surgery to allow time to have tissue submitted and tested before proceeding to Step 1 randomization. ** The patient must have a Cancer of the Prostate Risk Assessment Postsurgical (CAPRA-S) score >= 3. The CAPRA-S score is calculated by assigning points for PSA in ng/mL, Gleason score, 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. ** Tumor tissue specimen from radical prostatectomy must be available and ready to be shipped within 20 weeks post-surgery. * NOTE: Every effort should be made to submit adequate tumor tissue specimen to Decipher Biosciences for testing immediately. Decipher Biosciences will notify submitting institution of Decipher score results within 21 days of receipt of adequate tumor tissue specimens. Failure to submit adequate tissue will result in request for additional tissue and delays in testing and reporting

  • 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 * NOTE: Prior treatment with bicalutamide is permitted

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • INCLUSION CRITERIA FOR RANDOMIZATION (STEP 1)

  • Patient must be randomized to Step 1 a minimum of 6 weeks and a maximum of 24 weeks (168 days) from radical prostatectomy (RP)

  • For patients who did not have a Decipher score obtained through standard of care testing outside of the protocol prior to registration to Step 0, the Decipher score is > 0.6 assessed from the prostatectomy specimen submitted

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0- 2

  • Patients with a prior or concurrent malignancy within 5 years of Step 1 randomization, 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

  • Patient must be able to take oral medications

  • Patient must have a PSA < 0.2 ng/mL obtained within 2 weeks prior to Step 1 randomization

  • 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) within 24 weeks (168 days) prior to Step 1 randomization. If pre-operative risk does not support a need for CT abdomen/pelvis and/or bone scan imaging, the lack of baseline imaging due to low risk disease should be documented. * NOTE: A post-operative Decipher Score of > 0.6 indicates an increased risk of metastatic disease and a bone scan or CT scan is required prior to Step 1 randomization

  • Due to the potential harm through seminal transfer to an unborn fetus with the treatment regimens being used, sexually active patients must not expect to father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 28 days after the last dose of protocol treatment

  • Leukocytes >= 3,000/mcL (obtained within 4 weeks prior to Step 1 randomization)

  • Absolute neutrophil count (ANC) >= 1,000/mcL (obtained within 4 weeks prior to Step 1 randomization)

  • Platelets >= 75,000/mcL (obtained within 4 weeks prior to Step 1 randomization)

  • Hemoglobin (Hgb) > 8 g/dL (obtained within 4 weeks prior to Step 1 randomization)

  • Total bilirubin =< institutional upper limit of normal (ULN) (or =< 3 x ULN for patients with known Gilbert’s disease) (obtained within 4 weeks prior to Step 1 randomization)

  • 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 Step 1 randomization)

  • Glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2 estimated by Modification of Diet in Renal Disease (MDRD) formula (obtained within 4 weeks prior to Step 1 randomization)

  • EXCLUSION CRITERIA FOR RANDOMIZATION (STEP 1)

  • 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

United States
CA
Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: becomingapatient@coh.org

Los Angeles
Los Angeles County-USC Medical Center
Status: ACTIVE
Contact: Site Public Contact

USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact

Palo Alto
VA Palo Alto Health Care System
Status: ACTIVE
Contact: Site Public Contact

South Pasadena
City of Hope South Pasadena
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: becomingapatient@coh.org

Upland
City of Hope Upland
Status: ACTIVE
Contact: Site Public Contact
Email: becomingapatient@coh.org

CT
Hartford
Hartford Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

FL
Lakewood Ranch
GenesisCare USA - Lakewood Ranch
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

Miami Beach
Mount Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: yenrique@msmc.com

Plantation
GenesisCare USA - Plantation
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

HI
Aiea
Pali Momi Medical Center
Status: ACTIVE
Contact: Site Public Contact

Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
Status: ACTIVE
Contact: Site Public Contact
Email: i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Status: ACTIVE
Contact: Site Public Contact

Queen's Cancer Center - Kuakini
Status: ACTIVE
Contact: Site Public Contact

Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact

Straub Clinic and Hospital
Status: ACTIVE
Contact: Site Public Contact

The Cancer Center of Hawaii-Liliha
Status: ACTIVE
Contact: Site Public Contact

IA
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact

Iowa Lutheran Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact

Medical Oncology and Hematology Associates-Laurel
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: cancerresearch@mercydesmoines.org

West Des Moines
Methodist West Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

IL
Aurora
Rush - Copley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: Cancer.Research@rushcopley.com

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Carthage
Illinois CancerCare-Carthage
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Chicago
Northwestern University
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@northwestern.edu

University of Chicago Comprehensive Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Decatur
Cancer Care Specialists of Illinois - Decatur
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com

Elmhurst
Elmhurst Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: Jrohde@emhc.org

Eureka
Illinois CancerCare-Eureka
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Evanston
NorthShore University HealthSystem-Evanston Hospital
Status: ACTIVE
Contact: Site Public Contact

Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Glenview
NorthShore University HealthSystem-Glenbrook Hospital
Status: ACTIVE
Contact: Site Public Contact

Highland Park
NorthShore University HealthSystem-Highland Park Hospital
Status: ACTIVE
Contact: Site Public Contact

Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: cancertrials@northwestern.edu

Macomb
Illinois CancerCare-Macomb
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

Naperville
Edward Hospital / Cancer Center
Status: ACTIVE
Contact: Site Public Contact

New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@bsd.uchicago.edu

Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Methodist Medical Center of Illinois
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Princeton
Illinois CancerCare-Princeton
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

Springfield
Memorial Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: pallante.beth@mhsil.com

Southern Illinois University School of Medicine
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Springfield Clinic
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact

Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: Research@carle.com

The Carle Foundation Hospital
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: Research@carle.com

Washington
Illinois CancerCare - Washington
Status: ACTIVE
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com

IN
Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: iutrials@iu.edu

MA
Beverly
Beverly Hospital
Status: ACTIVE
Contact: Site Public Contact

Burlington
Lahey Hospital and Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@lahey.org

Gloucester
Addison Gilbert Hospital
Status: ACTIVE
Contact: Site Public Contact

Peabody
Lahey Medical Center-Peabody
Status: ACTIVE
Contact: Site Public Contact
Email: cancerclinicaltrials@lahey.org

MD
Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

MI
Clarkston
GenesisCare USA - Clarkston
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

Farmington Hills
GenesisCare USA - Farmington Hills
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

Macomb
GenesisCare USA - Macomb
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

Madison Heights
GenesisCare USA - Madison Heights
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

Troy
GenesisCare USA - Troy
Status: ACTIVE
Contact: Site Public Contact
Email: Rudi.Ross@usa.genesiscare.com

MN
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Cape Girardeau
Saint Francis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: sfmc@sfmc.net

Saint Louis
Mercy Hospital Saint Louis
Status: ACTIVE
Contact: Site Public Contact

MT
Bozeman
Bozeman Deaconess Hospital
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

NC
Clemmons
Wake Forest University at Clemmons
Status: ACTIVE
Contact: Site Public Contact

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact

ND
Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

NH
Concord
New Hampshire Oncology Hematology PA-Concord
Status: ACTIVE
Contact: Site Public Contact

Manchester
Solinsky Center for Cancer Care
Status: ACTIVE
Contact: Site Public Contact

NY
Bronx
Montefiore Medical Center-Einstein Campus
Status: ACTIVE
Contact: Site Public Contact
Email: eskwak@montefiore.org

OH
Cincinnati
University of Cincinnati Cancer Center-UC Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@uchealth.com

Toledo
University of Toledo
Status: ACTIVE
Contact: Site Public Contact

West Chester
University of Cincinnati Cancer Center-West Chester
Status: ACTIVE
Contact: Site Public Contact
Email: cancer@uchealth.com

OK
Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

PA
Hershey
Penn State Milton S Hershey Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: CTO@hmc.psu.edu

West Reading
Reading Hospital
Status: ACTIVE
Contact: Site Public Contact

SC
Charleston
Medical University of South Carolina
Status: ACTIVE
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Ralph H Johnson VA Medical Center
Status: ACTIVE
Contact: Site Public Contact
Email: ashley.salvo@va.gov

TX
Dallas
Parkland Memorial Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Fort Worth
UT Southwestern / Simmons Cancer Center-Fort Worth
Status: ACTIVE
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Richardson
UT Southwestern Clinical Center at Richardson / Plano
Status: ACTIVE
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu

San Antonio
University of Texas Health Science Center at San Antonio
Status: ACTIVE
Contact: Site Public Contact
Email: phoresearchoffice@uthscsa.edu

VA
Richmond
Virginia Commonwealth University / Massey Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: CTOclinops@vcu.edu

WI
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Madison
University of Wisconsin Carbone Cancer Center
Status: ACTIVE
Contact: Site Public Contact

William S Middleton VA Medical Center
Status: ACTIVE
Contact: Site Public Contact

Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

Weston
Marshfield Medical Center - Weston
Status: ACTIVE
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org

PRIMARY OBJECTIVE:
I. To determine whether 12 months (48 weeks) of androgen deprivation therapy (ADT) and darolutamide improves metastasis-free survival (MFS) compared to 12 months (48 weeks) of ADT plus placebo in men with high risk prostate cancer (defined by Cancer of the Prostate Risk Assessment Post-surgical [CAPRA-S] score >= 3 and a high Decipher score (> 0.6) [C3+D+]) that have undergone radical prostatectomy.

SECONDARY OBJECTIVES:
I. To determine whether 12 months (48 weeks) of ADT and darolutamide improves recurrence-free survival (RFS) compared to 12 months (48 weeks) of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.
II. To determine whether 12 months (48 weeks) of ADT and darolutamide improves event-free survival (EFS) compared to 12 months (48 weeks) of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.
III. To determine whether 12 months (48 weeks) of ADT and darolutamide improves overall survival (OS) compared to 12 months (48 weeks) of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.
IV. To determine the rate of testosterone recovery and time to testosterone recovery in each treatment arm.
V. To evaluate the safety and tolerability of ADT and darolutamide.

CORRELATIVE OBJECTIVES FOR EXPLORATORY BIOMARKERS:
I. To discover a novel gene expression signature in the Decipher transcriptome platforms that is predictive of clinical outcome, as defined by the primary and secondary objectives of this study, in response to ADT by intensification with darolutamide versus ADT alone.
II. To assess the prevalence of subclasses of established transcriptome expression signatures and prospectively validate their predictive value for ADT response, these include: (i) androgen receptor (AR) activity (ii) Basal-luminal subtyping based on modified PAM50, and (iii) ADT score. 
III. To assess whether the spectrum of high Decipher scores (> 0.6-1.0), prostate-specific antigen (PSA) levels at presentation and post-radical prostatectomy and final pathology variables affect the response and outcome to ADT and darolutamide.

QUALITY OF LIFE (QOL) OBJECTIVES:
I. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) total score, at 12 months (48 weeks) between the two arms. (Primary)
II. To compare the change in overall quality of life, measured by FACT-P total score, from baseline to 12 months (48 weeks) between the two arms. (Secondary)
III. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 12 months (48 weeks) between the two treatment arms. (Secondary)
IV. To compare the change in subjective patient-reported cognitive function (FACT-Cognitive [Cog]) from baseline to 12 months (48 weeks) between the treatment arms. (Exploratory)
V. To compare subjective patient-reported cognitive function (FACT-Cog scores) at 12 months (48 weeks) between the two treatment arms. (Exploratory)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive goserelin acetate, leuprolide acetate, triptorelin, or degarelix via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive a placebo four times daily (QID) for 52 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive goserelin acetate, leuprolide acetate, triptorelin, or degarelix via injection every 3 months for 12 months (4 injections), every 4 months for 12 months (3 injections), or every month for 12 months (12 injections) in the absence of disease progression or unacceptable toxicity. Patients also receive darolutamide QID for 52 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 36 months.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


EA8183 / ERADICATE Home Page
ECOG-ACRIN Cancer Research Group