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 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
Overall PI:
William Shipley, MD,
Massachusetts General Hospital
Site-responsible Investigators:
Irving Kaplan, MD,
Beth Israel Deaconess Medical Center
Wonsuk Warren Suh, MD,
Brigham and Women's Hospital
Contacts:
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100
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