Pasireotide (SOM230) With or Without Everolimus in Treating Patients With Hormone Resistant, Chemotherapy Naive Prostate Cancer

What Was Tested

This registered phase 2 trial tested Pasireotide.

It had two arms (groups): Cohort A (pasireotide) (active comparator) and Cohort B (pasireotide and everolimus) (experimental).

Patients receive pasireotide IM once every 4 weeks.

Patients receive pasireotide as in cohort A and everolimus PO QD.

The registry classes the interventions as drug and other.

More on the Plan

SOM230 is a new agent which can activate SSTR and block other key survival molecules/pathways such as phosphatidylinositol 3-kinases (PI3K), mitogen-activated protein (MAP) kinases (MAPK) signaling pathways.

One key survival pathway is mediated by an important molecule called mammalian target of rapamycin (mTOR).

Who Took Part

6 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Age minimum: 18 years old. Histological confirmation of prostatic adenocarcinoma. PSA \> or = to 2 ng/ml. PSA progression (serially rises on two occasions each at least one week apart) OR disease progression on imaging studies (CT scan or bone scan). Discontinuation of all antiandrogen, ketoconazole and investigational drugs for at least 4 weeks (6 weeks for bicalutamide) prior to study initiation.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: progressive pulmonary disease, such as advanced copd, pulmonary fibrosis, or supplemental o2 requirement; known cns disease, except for treated brain metastases; serum creatinine \>1.5 upper limit of normal or on dialysis.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.

It started in 2011-06 with completion listed for 2012-09-15.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants Alive and Progression Free After 12 Weeks of Treatment (time frame: 12 weeks after treatment).

It also tracked 3 secondary outcomes, for example Number of Participants Without New Bone Lesions After 12 Weeks of Treatment and Number of Participants With Progression Free Survival (PFS) Based on RECIST 1.1 Criteria.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 6 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 Pasireotide compound page, all human trials.