Adjuvant Androgen Suppression Plus Radiation Therapy for High-Risk Localized Adenocarcinoma Prostate

Inclusion Criteria

• •1. 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 (undissected pelvic lymph nodes \[Nx\]), i.e. lymph node dissection is not required;
• •2. Any type of radical prostatectomy will be permitted, including retropubic, perineal laparoscopic or robotically assisted. If performed, the number of lymph nodes removed per side of the pelvis and the extent of the pelvic lymph node dissection (obturator vs. extended lymph node dissection) should be noted. There is no time limit for the date of radical prostatectomy.
• •3. A post-radical prostatectomy entry PSA of \> 0 and \< 1 ng/ml at least 6 weeks after prostatectomy and within 30 days of registration.
• •4. One of the following pathologic/chemical classifications:
• •* T3N0/Nx disease with or without positive surgical margin; or;
• •* Gleason score of 8 or more;
• •* Pre prostatectomy PSA \> 20 ng/ml
• •5. KPS \> 70
• •6. Age ≥ 18;
• •7. No distant metastases, based upon the following minimum diagnostic workup:
• •8. History/physical examination (including digital rectal exam) within 8 wks prior to registration;
• •9. A CT scan or MRI of the abdomen and pelvis within 120 days prior to registration;
• •10. Bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or MRI must be obtained to rule out metastasis.
• •11. Adequate bone marrow function, within 90 days prior to registration, defined as follows:
• •* Platelets ≥ 100,000 cells/mm3 based upon CBC;
• •* Hemoglobin ≥ 10.0 g/dl based upon CBC
• •* AST or ALT \< 2 x the upper limit of normal within 90 days prior to registration;
• •12. Patients must sign a study-specific informed consent prior to study entry.