Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to moderate- to high-risk groups as listed in the Disease Characteristics of this abstract, type of radiotherapy boost (IMRT vs brachytherapy [Low-dose rate (LDR) using PPI or HDR]), and duration of androgen-deprivation therapy (short-term [4-6 months] vs long-term [32 months]). Patients are randomized to 1 of 2 treatment arms.
All patients receive neoadjuvant androgen-deprivation therapy comprising bicalutamide orally (PO) once daily or flutamide PO thrice daily for 4-6 months, and luteinizing hormone-releasing hormone (LHRH) agonist/antagonist therapy comprising leuprolide acetate, goserelin acetate, buserelin, triptorelin, or degarelix subcutaneously (SC) or intramuscularly (IM) every 1 to 3 months beginning 2 months prior to radiotherapy and continuing for 4-6 or 32 months.
Radiotherapy begins within 8 weeks after beginning LHRH agonist/antagonist injection.
Patients may undergo blood and urine sample collection for correlative studies. Primary tumor tissue samples may also be collected.
Patients may complete the Expanded Prostate Cancer Index Composite (EPIC), the PROMIS-Fatigue Short Form, and the EuroQol (EQ-5D) quality-of-life (QOL) questionnaires at baseline and periodically during treatment. Patients who participate in the QOL portion of the study must also agree to periodic blood collection.
After completion of study therapy, patients are followed up every 3 months for 1 year, every 6 months for 3 years, and then yearly thereafter.
DISEASE CHARACTERISTICS:
Pathologically (histologically or cytologically) proven diagnosis of prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:
Gleason score 7-10 + T1c-T2b (palpation) + PSA < 50 ng/ml (includes intermediate and high risk patients);
Gleason score 6 + T2c-T4 (palpation) + PSA < 50 ng/ml
-ORGleason score 6 + ≥ 50% (positive) biopsies + PSA < 50 ng/ml;
Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/ml. Patients previously diagnosed with low risk prostate cancer undergoing active surveillance who are re-biopsied and found to have unfavorable intermediate risk disease or favorable high risk disease according to the protocol criteria are eligible for enrollment within 180 days of the repeat biopsy procedure.
Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm.
*No evidence of bone metastases (M0) on bone scan within 120 days prior to registration (Na F PET/CT is an acceptable substitute).
Equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis.
*Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 120 days prior to registration.
Study entry PSA should not be obtained during the following time frames: (1) 10- day period following prostate biopsy; (2) following initiation of hormonal therapy; (3) within 30 days after discontinuation of finasteride; (4) within 90 days after discontinuation of dutasteride.
Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3;
Platelets ≥ 100,000 cells/mm3;
Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.);
Jonesboro, Arkansas 72401, United States
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Roseville, California 95661, United States
Sacramento, California 95817, United States
Vacaville, California 95687, United States
Miami, Florida 33136, United States
Chicago, Illinois 60657, United States
Elkton, Maryland 21921, United States
Brownstown, Michigan 48183, United States
Canandiaqua, New York 14424, United States
New York, New York 10032, United States
Morehead City, North Carolina 28557, United States
Wpafb, Ohio 45433, United States
Hilton Head Island, South Carolina 29926, United States
American Fork, Utah 84003, United States
Berlin Corners, Vermont 05602, United States
Yakima, Washington 98902, United States
Eau Claire, Wisconsin 54703, United States
Milwaukee, Wisconsin 53210, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States
Montreal, Quebec H3H 2R9, Canada