A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
N/A
N/A
Male
Prostate Cancer
Trial Information
A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate changes in prostate specific antigen (PSA) in patients with androgen independent prostate cancer who are treated with Sandostatin LAR.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Charles Ryan, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Institutional Review Board
Study ID:
UCSF055514
NCT ID:
NCT00510224
Start Date:
July 2007
Completion Date:
August 2009
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| University of California, San Francisco | San Francisco, California 94143 |
