Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Prostate Cancer
NCT ID: NCT00936390 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-095


RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Androgens can cause the growth of prostate cancer cells. Androgen-deprivation therapy may lessen the amount of androgens made by the body. It is not yet known whether radiation therapy is more effective with or without androgen-deprivation therapy in treating patients with prostate cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer.


Conducting Institutions:
Massachusetts General Hospital, Lowell General Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Jason Efstathiou, MD, Massachusetts General Hospital

Site-responsible Investigators:
Derek Chism, M.D., Massachusetts General Hospital North Shore Cancer Center
Matthew Katz, MD, Lowell General Hospital

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate diagnosed within the past 6 months and at intermediate-risk for recurrence by meeting ≥ 1 of the following criteria: - Gleason score > 7 - PSA > 10 and ≤ 20 ng/mL - Baseline serum PSA value performed within 60 days with an FDA-approved assay (e.g., Abbott, Hybritech) - Baseline PSA must not be obtained during any of the following time frames:10-day period after prostate biopsy, after initiation of androgen-deprivation therapy, or within the past 30 days after discontinuation of finasteride (90 days for dutasteride) - Clinical stage T2b or T2c disease - No patients with all 3 intermediate-risk factors who also have ≥ 50% of the number of their biopsy cores positive for cancer - The percentage of biopsy cores involved will only be considered with respect to eligibility for those patients with all 3 of the above risk factors (i.e., patients with one or two of the above risk factors are eligible irrespective of the percentage of biopsy cores involved) - Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT scan or MRI), nodal sampling, or dissection within the past 60 days (required for patients with 2-3 risk factors) - Abdominal imaging not required for a single intermediate-risk factor (these studies may be obtained at the discretion of the treating physician) - Lymph nodes that are equivocal or questionable by imaging allowed without biopsy if nodes ≤ 1.5 cm - Any node > 1.5 cm on imaging requires a negative biopsy - No evidence of bone metastases on bone scan within the past 60 days - Bone scan not required for patients with a single intermediate-risk factor (scan may be obtained at the discretion of the treating physician) - Equivocal bone scan findings allowed if plain film x-rays negative for metastasis PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - ANC ≥ 1,800/mm^3 - Platelet count ≥ 100,000/mm^3 - Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve level allowed) - Fertile patients must use effective contraception during and for the 3 months after cessation of protocol treatment - No invasive malignancy or hematological malignancy (e.g., leukemia, lymphoma, myeloma) within the past 5 years except adequately treated non-melanomatous skin cancer - Prior diagnoses of carcinoma in situ allowed - No severe or active co-morbidity with any of the following: - Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months - Transmural myocardial infarction within the past 6 months - Acute bacterial or fungal infection requiring intravenous antibiotics - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy, within the past 30 days - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Laboratory tests for liver function and coagulation parameters not required for entry into this protocol - AIDS based upon current CDC definition - HIV testing not required for entry into this protocol - HIV-seropositive patients who do not meet criteria for diagnosis of AIDS allowed PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior radical surgery (prostatectomy), high-intensity focused ultrasound, or cryosurgery for prostate cancer - No prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy - No finasteride within past 30 days (90 days for dutasteride) - No prior or concurrent cytotoxic chemotherapy for prostate cancer - Prior chemotherapy for a different cancer allowed - No prior radiotherapy (RT), including brachytherapy, to the region of the study cancer that would result in overlap of RT fields - Patients undergoing brachytherapy must have transrectal ultrasound confirmation of prostate volume < 60 cc, AUA score ≤ 15 within the past 60 days of registration, and no history of prior transurethral resection of the prostate (TURP) - TURP allowed for patients who receive external-beam radiation therapy only
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