Sandostatin for Patients With Androgen Independent Prostate Cancer

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer. Patients will receive Sandostatin LAR 30 mg intramuscularly every 28 days. Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent. The study will require 27 evaluable patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Novartis
• Treatments: Androgens; Octreotide

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate.

• Biochemical disease progression following androgen deprivation and therapy with at least one antiandrogen defined as three rises in PSA with PSA determinations at least 4 weeks apart and each PSA value > 0.2 ng/ml.

• Four weeks since prior therapy with Flutamide.

• Six weeks since prior therapy with Bicalutamide or Nilutamide.

• Current PSA > 5 ng/ml.

• Testosterone <50 ng/dL.

• SGPT (ALT) < 1.5 times upper limit of normal.

• Fasting blood glucose > 60 mg/dL.

• ECOG performance status 0, 1 or 2.

• No visceral or bony metastatic disease (Lymph node only metastases are allowed).

• No prior chemotherapy for prostate cancer.

• No current treatment with insulin or an oral hypoglycemic.

• No history of treatment with octreotide analogs for prostate cancer.

• No NYHA Class 3 or 4 cardiac status.

Exclusion Criteria:

• Diabetes Mellitus requiring medical therapy and/or that which is not controlled by dietary means (HbA1C<6.0).

• A history of gallstones that has been clinically significant. Patients who have undergone cholecystectomy are eligible.

• Other concomitant medical or psychiatric condition which would make it undesirable, in the physician's opinion, for the patient to participate in the protocol or would jeopardize compliance with the protocol requirements.

• Prior treatment with chemotherapy for prostate cancer.

• No current treatment with Saw Palmetto, or Proscar. Patients must be off these medicines for more than 4 weeks.