Sandostatin for Patients With Androgen Independent Prostate Cancer
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer|
- PSA Response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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.
- Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1. [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]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).
- Grade 4-5 Adverse Events [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Pre Versus Post Treatment Mitogenic Effects. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Sandostatin 30mg intramuscular every 28 days
To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.
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.
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Charles Ryan, MD||University of California, San Francisco|