Eligibility Cardiovascular Diseases NCT00127452

men and women

at least 3 months but no more than 8 years prior to study entry, undergone a radical prostatectomy for stage t1b – t3c, n0-n1, m0 disease, with or without subsequent adjuvant or salvage radiation therapy. patients who experience their first psa recurrence within 2 years post completion of initial therapy of curative intent are eligible without consideration of the gleason score of the tumor specimen.* patients who experience their first psa relapse between 2 and 8 years post completion of initial therapy of curative intent are eligible only if the gleason score of the tumor specimen was > 7; (* for patients who received adjuvant radiation, the date of the final dose of radiotherapy is used to mark the date of completion of therapy of curative intent. for patients who received salvage radiation for post-operative psa recurrence but no adjuvant radiation, the date of surgery marks the date of completion of therapy of curative intent.)

therapeutic psa response to primary therapy below 0.4 ng/ml;

tumor specimen positive for pap, the vaccine’s target. immunohistological staining of a specimen from the surgically excised tumor for expression of pap is conducted by impath, and may be completed even after lh-rh-analogue placement, as long as a positive (+) result is confirmed prior to randomization (week 0). if a slide of the tumor cannot be obtained from the pathology archive, a chart record from a pre-surgery blood sample showing serum pap elevated above the upper limit of the local reference range may serve as a proxy.