Prostate Cancer Clinical Trial

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

Summary

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 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.

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Full Description

PRIMARY OBJECTIVE:

I. To determine whether 12 months of androgen deprivation therapy (ADT) and darolutamide improves metastasis-free survival (MFS) compared to 12 months 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+]) who have undergone radical prostatectomy.

SECONDARY OBJECTIVES:

I. To determine whether 12 months of ADT and darolutamide improves recurrence-free survival (RFS) compared to 12 months of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.

II. To determine whether 12 months of ADT and darolutamide improves event-free survival (EFS) compared to 12 months of ADT plus placebo in men with high-risk prostate cancer that have undergone radical prostatectomy.

III. To determine whether 12 months of ADT and darolutamide improves overall survival (OS) compared to 12 months 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 (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 (RP) 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 18 months between the two arms. (Primary) II. To compare the change in overall quality of life, measured by FACT-P total score, from baseline to 18 months between the two arms. (Secondary) III. To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy [FACIT]-Fatigue scores) at 12 months 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 between the treatment arms. (Exploratory) V. To compare subjective patient-reported cognitive function (FACT-Cog scores) at 12 months between the two treatment arms. (Exploratory)

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: 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.

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

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

27

Study ID:

NCT04484818

Recruitment Status:

Active, not recruiting

Sponsor:

ECOG-ACRIN Cancer Research Group

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There are 101 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Los Angeles County-USC Medical Center
Los Angeles California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Stanford Cancer Institute Palo Alto
Palo Alto California, 94304, United States
VA Palo Alto Health Care System
Palo Alto California, 94304, United States
City of Hope South Pasadena
South Pasadena California, 91030, United States
City of Hope Upland
Upland California, 91786, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
GenesisCare USA - Lakewood Ranch
Lakewood Ranch Florida, 34202, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
GenesisCare USA - Plantation
Plantation Florida, 33324, United States
Pali Momi Medical Center
'Aiea Hawaii, 96701, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu Hawaii, 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu Hawaii, 96813, United States
Queen's Medical Center
Honolulu Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu Hawaii, 96813, United States
Queen's Cancer Center - Kuakini
Honolulu Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu Hawaii, 96817, United States
Rush - Copley Medical Center
Aurora Illinois, 60504, 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
Northwestern University
Chicago Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Carle on Vermilion
Danville Illinois, 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur Illinois, 62526, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham Illinois, 62401, United States
Crossroads Cancer Center
Effingham Illinois, 62401, United States
Elmhurst Memorial Hospital
Elmhurst Illinois, 60126, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview Illinois, 60026, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park Illinois, 60035, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Northwestern Medicine Lake Forest Hospital
Lake Forest Illinois, 60045, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon Illinois, 61938, United States
Edward Hospital/Cancer Center
Naperville Illinois, 60540, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox Illinois, 60451, 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
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
Southern Illinois University School of Medicine
Springfield Illinois, 62702, United States
Springfield Clinic
Springfield Illinois, 62702, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
The Carle Foundation Hospital
Urbana Illinois, 61801, United States
Illinois CancerCare - Washington
Washington Illinois, 61571, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Broadlawns Medical Center
Des Moines Iowa, 50314, United States
Mission Cancer and Blood - Laurel
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Methodist West Hospital
West Des Moines Iowa, 50266, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Beverly Hospital
Beverly Massachusetts, 01915, United States
Lahey Hospital and Medical Center
Burlington Massachusetts, 01805, United States
Addison Gilbert Hospital
Gloucester Massachusetts, 01930, United States
Lahey Medical Center-Peabody
Peabody Massachusetts, 01960, United States
Winchester Hospital
Winchester Massachusetts, 01890, United States
GenesisCare USA - Clarkston
Clarkston Michigan, 48346, United States
GenesisCare USA - Farmington Hills
Farmington Hills Michigan, 48334, United States
GenesisCare USA - Macomb
Macomb Michigan, 48044, United States
GenesisCare USA - Madison Heights
Madison Heights Michigan, 48071, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
William Beaumont Hospital - Troy
Troy Michigan, 48085, United States
GenesisCare USA - Troy
Troy Michigan, 48098, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63703, United States
Mercy Hospital Saint Louis
Saint Louis Missouri, 63141, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
New Hampshire Oncology Hematology PA-Concord
Concord New Hampshire, 03301, United States
Solinsky Center for Cancer Care
Manchester New Hampshire, 03103, United States
Montefiore Medical Center-Einstein Campus
Bronx New York, 10461, United States
Wake Forest University at Clemmons
Clemmons North Carolina, 27012, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, 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
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati Ohio, 45219, United States
University of Toledo
Toledo Ohio, 43614, United States
University of Cincinnati Cancer Center-West Chester
West Chester Ohio, 45069, United States
Genesis Healthcare System Cancer Care Center
Zanesville Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Geisinger Medical Center
Danville Pennsylvania, 17822, United States
Penn State Milton S Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Reading Hospital
West Reading Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre Pennsylvania, 18711, United States
Ralph H Johnson VA Medical Center
Charleston South Carolina, 29401, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
Parkland Memorial Hospital
Dallas Texas, 75235, 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
UT Southwestern Clinical Center at Richardson/Plano
Richardson Texas, 75080, United States
Audie L Murphy VA Hospital
San Antonio Texas, 78229, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire Wisconsin, 54701, United States
William S Middleton VA Medical Center
Madison Wisconsin, 53705, United States
University of Wisconsin Carbone Cancer Center
Madison Wisconsin, 53792, United States
Marshfield Medical Center-Marshfield
Marshfield Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, 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
Marshfield Medical Center - Weston
Weston Wisconsin, 54476, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

27

Study ID:

NCT04484818

Recruitment Status:

Active, not recruiting

Sponsor:


ECOG-ACRIN Cancer Research Group

How clear is this clinincal trial information?

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