Clinical trial NCT00510224: Sandostatin for Patients With Androgen Independent Prostate Cancer
Official title: A Phase II Study of the Somatostatin Analog Sandostatin LAR in Patients With Androgen Independent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2007-08-01
Enrollment: 13
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PSA Response
timeFrame: 12 weeks
Secondary outcomes:
measure: Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1.
timeFrame: Baseline, 12 weeks
measure: Grade 4-5 Adverse Events
timeFrame: 12 weeks
measure: Pre Versus Post Treatment Mitogenic Effects.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Charles Ryan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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-resistant prostate cancer: results of a phase II study. Urol Oncol. 2012 Jul-Aug;30(4):408-14. doi: 10.1016/j.urolonc.2010.06.014. Epub 2010 Oct 2.