Sandostatin for Patients With Androgen Independent Prostate Cancer

What Was Tested

This registered phase 2 trial tested Octreotide.

This is an open label, single center Phase II trial of Sandostatin LAR in patients with hormone refractory prostate cancer.

Patients will be treated until the time of disease progression, unacceptable toxicity or withdrawal of consent.

It had 1 arm (groups): 1 (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 13 actual participants took part.

It was open to men only.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate. 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.

The full record lists 14 inclusion and 5 exclusion criteria; among the exclusions: diabetes mellitus requiring medical therapy and/or that which is not controlled by dietary means (hba1c\<6.0); 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.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Octreotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2007-07 with completion listed for 2009-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: PSA Response (time frame: 12 weeks).

It also tracked 3 secondary outcomes, for example Pre-post Percent Change in Circulating Levels of IGF-1 and IGF-Binding Protein 1, Grade 4-5 Adverse Events and Pre Versus Post Treatment Mitogenic Effects.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 13 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.