Sandostatin for Patients With Androgen Independent Prostate Cancer

Phase 2TerminatedNCT00510224

University of California, San Francisco13 enrolled

Overview

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.

Primary Objective: To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR. Secondary Objective: To evaluate the effects of Sandostatin LAR on circulating levels of Insulin Growth Factor-1 and Insulin Growth Factor Binding Protein 1. To evaluate the safety of Sandostatin LAR in this patient population. To evaluate the pre versus post treatment mitogenic effects of serum derived from subjects with prostate cancer compared to pretreatment serum. Patients with androgen independent prostate cancer who do not have bone or visceral metastases are selected for this trial because they are a patient population that is likely to have no symptoms from the disease or rapid progression that would suggest the need for chemotherapy. Additionally, given the preclinical data suggesting that IGF-1 expression and signaling occurs concomitantly with the onset of androgen independent growth, it is felt that testing in the "early" androgen independent state is warranted. This trial is consistent with overall goal to develop IGF-1 targeted therapies in patients with disease progression and a lower disease burden.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

SandostatinDRUG

Sandostatin 30mg intramuscular every 28 days

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

Outcomes

Primary Outcomes

PSA Response

Number of participants with a PSA decline of at least 50% from Baseline during the first 3 cycles of therapy, confirmed by a second measurement at least 2 weeks later.

Time frame: 12 weeks

Secondary Outcomes

Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.

Serum was batched and IGF and IGFBP levels were assayed at one time at the end of the study using an enzyme-linked immunoabsorbent assay (ELISA) method by Diagnostic Systems Laboratories (Webster, TX).

Time frame: Baseline, 12 weeks

Grade 4-5 Adverse Events

Time frame: 12 weeks

Pre Versus Post Treatment Mitogenic Effects.

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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