Overview

PS-341 Followed by Removal of Prostate for Those With Prostate Cancer

Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Following pretreatment evaluation, patients receive PS-341 by intravenous push weekly for 4 consecutive weeks followed by a 24-72 hour rest period. This schedule consists of one treatment cycle. Upon the completion of 4 weeks of PS-341 followed by a 24-72 hour rest period, radical prostatectomy will be performed. Surgery will be delayed if there is any bleeding abnormality (bleeding time greater than 10 minutes) and until platelet count is more than or equal to 100,000 and coagulation profile (PT, PTT) is normal. If at the time of surgery a patient is found to have positive lymph nodes, prostatectomy will be abandoned, the prostate will be biopsied, and the patient will be offered other treatment modalities (hormones, radiation therapy).
Phase:
Phase 2
Details
Lead Sponsor:
Baylor College of Medicine
Collaborator:
Millennium Pharmaceuticals, Inc.
Treatments:
Bortezomib