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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

• Histologic proof of prostatic adenocarcinoma without evidence of regional and/or distant metastasis, clinical stage T1, T2 or T3 with high grade disease (Gleason's grade 7 or above).

• Recent (less than or equal to 6 weeks prior to study entry) negative bone scan and CT scan of abdomen/pelvis.

• Appropriate surgical candidate for radical prostatectomy and a performance status of less than or equal to 2 (Zubrod scale).

• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count greater than or equal to 1,500 and platelet count of greater than or equal to 100,000, adequate hepatic function with a bilirubin less than or equal to 1.5 mg % and SGPT less than 2.5x the upper limits of normal, adequate renal function defined as serum creatinine less than or equal to 2.0 mg %.

• Patients must have normal coagulation profile (PT, PTT) and no history of substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to local use only (for control of central line patency).

• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution.

• Patients screened and found eligible for the study, but not wanting to participate for any reason, will be followed along with the patients enrolled in the study in an effort to obtain outcome information (as historical information for design of future trials).

• No evidence of bifascicular block or active ischemia on EKG.

• Patients must have no history of congestive heart failure or previous MI.

Exclusion Criteria:

• Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or other investigational status drug.

• Unable to tolerate transrectal ultrasound.

• Patients who are not appropriate surgical candidates for radical prostatectomy based on the evaluation of co-existent medical diseases and competing causes of death. Patients with uncontrolled cardiac, hepatic, renal or neurologic/psychiatric disorder are not eligible.

• Patients who are HIV positive or have chronic hepatitis B or C infections are not eligible.

• Patients on steroid medications are not eligible.

• Patients with uncontrolled and symptomatic orthostatic hypotension or uncontrolled hypertension are not eligible.

• Patients with significant arteriosclerotic disease, as defined by a previous arterial bypass, claudication limiting activity, or a history of cerebrovascular events within the last year (including TIA) are not eligible.

• Patients with diabetes mellitus requiring insulin or oral hypoglycemics for more than 5 years are not eligible.

• Patient has greater than or equal to grade 1 peripheral neuropathy within 14 days before enrollment.

• Hypersensitivity to boron, mannitol, or bortezomib.