A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.
Charles Ryan, MD
University of California, San Francisco
United States: Institutional Review Board
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