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

Completed · Phase 2/Phase 3

Conditions studied: Stage I Prostate Adenocarcinoma AJCC v7, Stage II Prostate Adenocarcinoma AJCC v7, Stage III Prostate Adenocarcinoma AJCC v7

In brief

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.

Key facts

Study ID

NCT03070886

Run by

NRG Oncology

People needed

612

Starts

2017-04-05

Expected to finish

2025-10-31

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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