Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Prostate Cancer
NCT ID: NCT00567580 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 08-046

 

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer. PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Massachusetts General Hospital, Lowell General Hospital, Brigham and Women's Hospital

Overall PI:
William Shipley, MD, Massachusetts General Hospital

Site-responsible Investigators:
Irving Kaplan, MD, Beth Israel Deaconess Medical Center
Paul Nguyen, MD, Brigham and Women's Hospital
Matthew Katz, MD, Lowell General Hospital

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: - Adenocarcinoma of the prostate treated primarily with radical prostatectomy - Pathologically proven to be lymph node-negative by pelvic lymphadenectomy (N0) or lymph node status pathologically unknown (Nx [undissected pelvic lymph nodes because lymph node dissection is not required]) - Any type of radical prostatectomy allowed, including retropubic, perineal, laparoscopic or robotically assisted - Meets 1 of the following pathologic classifications: - T3 N0/Nx disease - T2 N0/Nx disease with or without positive prostatectomy margins - N1 patients are ineligible, as are those with pelvic lymph node enlargement ≥ 1.5 cm in greatest dimension by CT scan or MRI of the pelvis, unless the enlarged lymph node is negative - Prostatectomy Gleason score of 8 or less - A post-radical prostatectomy entry PSA of ≥ 0.1 and ≤ 1.0 ng/mL at least 6 weeks after prostatectomy and within 30 days of registration - Serum total testosterone ≥ 40% of the lower limit of normal (patients who have had a unilateral orchiectomy are eligible as long as this requirement is met) - No distant metastases based on history/physical examination, CT scan or MRI of the abdomen and pelvis, and bone scan - No palpable prostatic fossa abnormality/mass suggestive of recurrence, unless shown by biopsy under ultrasound guidance not to contain cancer PATIENT CHARACTERISTICS: - Zubrod performance status 0-1 - Platelets ≥ 100,000/mm^3 - Hemoglobin ≥ 10.0 g/dL (the use of transfusion or other intervention to achieve this is allowed) - AST or ALT < 2 x upper limit of normal - No prior invasive malignancy (except nonmelanoma skin cancer) unless disease-free for a minimum of 5 years (e.g., carcinoma in situ of the oral cavity is permissible) - No severe, active co-morbidity, including any of the following: - History of inflammatory bowel disease - History of hepatitis B or C - 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 at the time of registration - Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration - Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects - Acquired immune deficiency syndrome (AIDS) based upon current CDC definition - HIV testing is not required for entry - No prior allergic reaction to the study drug(s) involved in this protocol PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No androgen deprivation therapy started prior to prostatectomy for > 6 months duration - No androgen deprivation therapy started after prostatectomy and prior to registration - No prior pelvic radiotherapy
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