Clinical Trial Details

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Study ID RTOG 0534
Investigator
Alan Pollack, MD, PhD,   Fox Chase Cancer Center
Leonard G. Gomella, MD,   Jefferson Medical College of Thomas Jefferson University
Joycelyn L. Speight, MD, PhD,   University of California, San Francisco
Title 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
Conditions Prostate Cancer
Interventions Drug: bicalutamide
Drug: flutamide
Radiation: radiation therapy
Phase Phase 3
Purpose 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.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
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 with or without positive prostatectomy margins - 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 9 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)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2 x upper limit of normal
  • No prior invasive malignancy (except nonmelanoma skin cancer) or superficial bladder 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 Centers for Disease Control (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
  • More than 5 years since prior chemotherapy for any other disease site
  • No androgen-deprivation therapy started prior to prostatectomy for > 6 months duration - The use of finasteride or dutasteride (± tamsulosin) for longer periods prior to prostatectomy is acceptable
  • No androgen-deprivation therapy started after prostatectomy and prior to registration - The use of finasteride or dutasteride (± tamsulosin) after prostatectomy is not acceptable, it must be stopped within 3 months after prostatectomy
  • No neoadjuvant chemotherapy before or after prostatectomy
  • No prior cryosurgery or brachytherapy of the prostate (prostatectomy should be the primary treatment and not a salvage procedure)
  • No prior pelvic radiotherapy
  • Study Location
    Adams Cancer Center
    Gettysburg, Pennsylvania, 17325
    Contact Amit B. Shah
    717-741-8180
    Information objtained from ClinicalTrials.gov, on 10/31/2014. For additional information about this and other clinical trials, visit http://clinicaltrials.gov.
    Please refer to this study by its ClinicalTrials.gov identifier: NCT00567580


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