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ACTIVE NOT RECRUITING

NCT03070886

PHASE2/PHASE3

Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Official title: Phase II-III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy With or Without Adjuvant Docetaxel

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

612

Start Date

2017-04-05

Completion Date

2030-10-31

Last Updated

2026-09-14

Healthy Volunteers

Conditions

Stage I Prostate Adenocarcinoma AJCC v7 Stage II Prostate Adenocarcinoma AJCC v7 Stage III Prostate Adenocarcinoma AJCC v7

Interventions

DRUG

Bicalutamide

Given orally (PO)

DRUG

Degarelix

Given IM

DRUG

Docetaxel

Given IV

RADIATION

External Beam Radiation Therapy

Undergo external beam radiation therapy

DRUG

Flutamide

Given PO

DRUG

Goserelin

Given IM

DRUG

Goserelin Acetate

Given IM

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Leuprolide

Given intramuscularly (IM)

DRUG

Leuprolide Acetate

Given IM

DRUG

Nilutamide

Drug

Inclusion Criteria: * Patients post-prostatectomy with baseline Gleason \>= 7 (per prostatectomy pathology) * Baseline PSA prior to start of androgen deprivation therapy nadir \>= 0.2 ng/ml (post-operative value is never undetectable) obtained prior to step 1 registration * Baseline testosterone level obtained post-prostatectomy prior to start of androgen deprivation therapy and prior to step 1 registration * Pathologically (histologically) proven diagnosis of adenocarcinoma of the prostate as confirmed at time of prostatectomy; prostatectomy must have been performed within 365 days (1 year) prior to step 1 registrationand any type of radical prostatectomy is permitted, including retropubic, perineal, laparoscopic or robotically assisted; (please note: Prior ablative treatment for benign prostatic hypertrophy or focal high-intensity focused ultrasound therapy \[HIFU\] prior to prostatectomy is allowed) * Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform * Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation * Prior androgen deprivation (luteinizing hormone-releasing hormone \[LHRH\] agonist and/or non-steroidal anti-androgen) is allowed if: * Androgen deprivation therapy was initiated within 30 days prior to study enrollment * Androgen deprivation therapy was given for ≤ 90 days duration prior to radical prostatectomy * Please note: Finasteride or dutasteride must be stopped before treatment but should not determine eligibility * Pathologically lymph node negative by pelvic lymphadenectomy (pN0) or lymph node status pathologically unknown (undissected pelvic lymph nodes \[pNx\]) * Any pT-stage based on American Joint Committee on Cancer 7th edition eligible; study entry will be based on the following diagnostic workup: * History/physical examination within 60 days prior to step 1 registration * Negative distant metastatic workup: * A computed tomography (CT) scan of the abdomen and pelvis (with contrast \[CT without contrast is permitted if the patient is not a candidate for contrast, i.e., renal function or allergy\]) or magnetic resonance imaging (MRI) of the pelvis within 120 days prior to step 1 registration; (Please note: Lymph nodes will be considered negative (NO)if they are =\< 1.5 cm short axis); * Bone scan within 120 days prior to step 1 registration; (please note: a sodium fluoride \[NaF\] positron emission tomography \[PET\]/CT is an acceptable substitute and if the bone scan is suspicious, a plain x-ray, CT scan, NaF PET/CT and/or MRI must be obtained to rule out metastasis; Axumin scans are not allowed for determination of eligibility \[e.g. a positive Axumin can in the setting of negative bonescan and CT does not exclude a patient from being eligible for enrollment\]). * Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1 within 60 days prior to step 1 registration * Platelets \>= 100,000 cell/mm\^3 (within 60 days prior to step 1 registration based upon a complete blood count \[CBC\]) * Hemoglobin \>= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 10.0 g/dl is NOT allowed) (within 60 days prior to step 1 registration based upon a CBC) * Absolute neutrophil count \>= 1500 cells/mm\^3 (within 60 days prior to step 1 registration based upon a CBC) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 1.5 x the upper limit of normal (within 60 days prior to step 1 registration) * Total bilirubin (=\< 1.5 mg/dl) normal unless history of Gilbert's syndrome (within 60 days prior to step 1 registration) * The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration Exclusion Criteria: * Definitive clinical or radiologic evidence of metastatic disease * Prior invasive malignancy (except non-melanomatous skin cancer or other in-situ malignancies, or stage Ta bladder cancer) unless disease free for a minimum of 2 years * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable if completed more than two years prior to step 1 registration; prior androgen deprivation is allowed * Prior whole gland ablative therapy (i.e. cryoablation or high intensity focused ultrasound \[HIFU\]) for prostate cancer is not allowed * Prostatectomy performed greater than 365 days (1 year) prior to step 1 registration * Severe and/or active co-morbidity defined as follows: * History of inflammatory bowel disease * History of active hepatitis B or C; blood tests are not required to determine if the patient has had hepatitis B or C, unless the patient reports a history of hepatitis * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of step 1 registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within 15 days of step 1 registration or precluding study therapy at the time of step 1 registration * Uncontrolled severe illness or medical condition (including uncontrolled diabetes), which in the judgment of the treating physician would make the administration of chemotherapy inadvisable * Human immunodeficiency virus (HIV) positive with cluster of differentiation 4 (CD4) count \< 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count \>= 200 cells/microliter within 30 days prior to step 1 registration; note also that HIV testing is not required for eligibility for this protocol

Locations (313)

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

University of Arizona Cancer Center-Orange Grove Campus

Tucson, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

Adventist Health Cancer Care Center Chico

Chico, California, United States

Kaiser Permanente Dublin

Dublin, California, United States

Kaiser Permanente-Fremont

Fremont, California, United States

Fresno Cancer Center

Fresno, California, United States

Kaiser Permanente-Fresno

Fresno, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Kaiser Permanente-Modesto

Modesto, California, United States

Kaiser Permanente Oakland-Broadway

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Kaiser Permanente-Rancho Cordova Cancer Center

Rancho Cordova, California, United States

Kaiser Permanente-Redwood City

Redwood City, California, United States

Kaiser Permanente-Richmond

Richmond, California, United States

Rohnert Park Cancer Center

Rohnert Park, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, United States

The Permanente Medical Group-Roseville Radiation Oncology

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

Kaiser Permanente-South Sacramento

Sacramento, California, United States

South Sacramento Cancer Center

Sacramento, California, United States

Kaiser Permanente Sacramento Medical Center

Sacramento, California, United States

Naval Medical Center -San Diego

San Diego, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, United States

Kaiser Permanente San Leandro

San Leandro, California, United States

Kaiser Permanente-San Rafael

San Rafael, California, United States

Kaiser San Rafael-Gallinas

San Rafael, California, United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California, United States

Kaiser Permanente Cancer Treatment Center

South San Francisco, California, United States

Kaiser Permanente-South San Francisco

South San Francisco, California, United States

Kaiser Permanente-Stockton

Stockton, California, United States

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, United States

Kaiser Permanente-Walnut Creek

Walnut Creek, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

GenesisCare USA - Aventura FP

Aventura, Florida, United States

GenesisCare USA - Aventura

Aventura, Florida, United States

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

AdventHealth Celebration

Celebration, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

GenesisCare USA - Key West

Key West, Florida, United States

AdventHealth Kissimmee

Kissimmee, Florida, United States

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

GenesisCare USA - Lakewood Ranch

Lakewood Rch, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

AdventHealth Orlando

Orlando, Florida, United States

GenesisCare USA - Plantation

Plantation, Florida, United States

Grady Health System