Sandostatin for Patients With Androgen Independent Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00510224
• Other study ID #: UCSF055514
• Status: Terminated
• Phase: Phase 2
• First received: July 30, 2007
• Last updated: October 17, 2013
• Start date: July 2007
• Est. completion date: August 2009

Study information

• Verified date: October 2013
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Sandostatin
Sandostatin 30mg intramuscular every 28 days

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Friedlander TW, Weinberg VK, Small EJ, Sharib J, Harzstark AL, Lin AM, Fong L, Ryan CJ. Effect of the somatostatin analog octreotide acetate on circulating insulin-like growth factor-1 and related peptides in patients with non-metastatic castration-resist — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No
Secondary	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).	Baseline, 12 weeks	No
Secondary	Grade 4-5 Adverse Events		12 weeks	Yes
Secondary	Pre Versus Post Treatment Mitogenic Effects.		12 Weeks	No