Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study
Prostate Carcinoma
About this trial
This is an interventional treatment trial for Prostate Carcinoma
Eligibility Criteria
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
Sites / Locations
- City of Hope Comprehensive Cancer Center
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- Stanford Cancer Institute Palo Alto
- VA Palo Alto Health Care System
- City of Hope South Pasadena
- City of Hope Upland
- Hartford Hospital
- GenesisCare USA - Lakewood Ranch
- Mount Sinai Medical Center
- GenesisCare USA - Plantation
- Pali Momi Medical Center
- Hawaii Cancer Care Inc - Waterfront Plaza
- Queen's Cancer Cenrer - POB I
- Queen's Medical Center
- Straub Clinic and Hospital
- Queen's Cancer Center - Kuakini
- The Cancer Center of Hawaii-Liliha
- Rush - Copley Medical Center
- Illinois CancerCare-Bloomington
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Northwestern University
- University of Chicago Comprehensive Cancer Center
- Carle on Vermilion
- Cancer Care Specialists of Illinois - Decatur
- Decatur Memorial Hospital
- Carle Physician Group-Effingham
- Crossroads Cancer Center
- Elmhurst Memorial Hospital
- Illinois CancerCare-Eureka
- NorthShore University HealthSystem-Evanston Hospital
- Illinois CancerCare-Galesburg
- NorthShore University HealthSystem-Glenbrook Hospital
- NorthShore University HealthSystem-Highland Park Hospital
- Illinois CancerCare-Kewanee Clinic
- Northwestern Medicine Lake Forest Hospital
- Illinois CancerCare-Macomb
- Carle Physician Group-Mattoon/Charleston
- Edward Hospital/Cancer Center
- UC Comprehensive Cancer Center at Silver Cross
- Illinois CancerCare-Ottawa Clinic
- Illinois CancerCare-Pekin
- Illinois CancerCare-Peoria
- Methodist Medical Center of Illinois
- Illinois CancerCare-Peru
- Illinois CancerCare-Princeton
- Southern Illinois University School of Medicine
- Springfield Clinic
- Memorial Medical Center
- Carle Cancer Center
- The Carle Foundation Hospital
- Illinois CancerCare - Washington
- Indiana University/Melvin and Bren Simon Cancer Center
- Medical Oncology and Hematology Associates-West Des Moines
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des Moines
- Broadlawns Medical Center
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- Methodist West Hospital
- Johns Hopkins University/Sidney Kimmel Cancer Center
- Beverly Hospital
- Lahey Hospital and Medical Center
- Addison Gilbert Hospital
- Lahey Medical Center-Peabody
- Winchester Hospital
- GenesisCare USA - Clarkston
- GenesisCare USA - Farmington Hills
- GenesisCare USA - Macomb
- GenesisCare USA - Madison Heights
- William Beaumont Hospital-Royal Oak
- William Beaumont Hospital - Troy
- GenesisCare USA - Troy
- Unity Hospital
- Minnesota Oncology Hematology PA-Maplewood
- Regions Hospital
- Saint Francis Medical Center
- Mercy Hospital Saint Louis
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- New Hampshire Oncology Hematology PA-Concord
- Solinsky Center for Cancer Care
- Montefiore Medical Center-Einstein Campus
- Wake Forest University at Clemmons
- Wake Forest University Health Sciences
- Sanford Bismarck Medical Center
- Sanford Broadway Medical Center
- Sanford Roger Maris Cancer Center
- University of Cincinnati Cancer Center-UC Medical Center
- University of Toledo
- University of Cincinnati Cancer Center-West Chester
- Genesis Healthcare System Cancer Care Center
- University of Oklahoma Health Sciences Center
- Geisinger Medical Center
- Penn State Milton S Hershey Medical Center
- Reading Hospital
- Geisinger Wyoming Valley/Henry Cancer Center
- Ralph H Johnson VA Medical Center
- Medical University of South Carolina
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- UT Southwestern Clinical Center at Richardson/Plano
- Audie L Murphy VA Hospital
- University of Texas Health Science Center at San Antonio
- Virginia Commonwealth University/Massey Cancer Center
- Marshfield Medical Center-EC Cancer Center
- William S Middleton VA Medical Center
- University of Wisconsin Carbone Cancer Center
- Marshfield Medical Center-Marshfield
- Marshfield Clinic-Minocqua Center
- Marshfield Medical Center-Rice Lake
- Marshfield Medical Center-River Region at Stevens Point
- Marshfield Medical Center - Weston
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm A (ADT, placebo)
Arm B (ADT, darolutamide)
Patients receive goserelin acetate, leuprolide acetate, or triptorelin 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.
Patients receive goserelin acetate, leuprolide acetate, or triptorelin 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.