Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

What Was Tested

In this phase 2 trial, researchers set out to test Octreotide.

It had 1 arm (groups): Supportive care (management of therapy complications) (experimental).

Patients receive cabazitaxel IV over 1 hour on day 1, prednisone PO QD, and octreotide pamoate IM on day 1. Patients also receive octreotide acetate SC TID on days 1-14 of course 1 only. Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

The registry classes the interventions as drug and other.

More on the Plan

Prostate-specific antigen (PSA) response rate.

OUTLINE: Patients receive cabazitaxel as intravenous (IV) infusion over 1 hour on day 1, prednisone by mouth (PO) every day (QD), and octreotide pamoate given as intramuscular (IM) injection on day 1.

Patients also receive octreotide acetate as a subcutaneous (SC) injection three times a day (TID) on days 1-14 of course 1 only.

Treatment with cabazitaxel repeats every 21 days and treatment with prednisone and octreotide pamoate repeats every 4 weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity.

Who Took Part

9 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: Measurable disease on computed tomography (CT) or evaluable disease with an elevated PSA. Eastern Cooperative Oncology Group (ECOG) performance score of 0-2. Absolute neutrophil count (ANC) more than or equal to 1500/ul. Platelet count more than or equal to 100,000/ul. Serum creatinine less than or equal to 1.5x the upper limit of normal (ULN).

The full record lists 15 inclusion and 18 exclusion criteria; among the exclusions: treatment with radiotherapy, chemotherapy or any investigational agent in the prior 4 weeks; major surgery in the prior 4 weeks; prior treatment with cabazitaxel.

How the Study Was Run

Design: single-group and open-label.

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

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

It started in 2012-07 with completion listed for 2014-10.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Development of Grade 2 plus diarrhea (time frame: Baseline through 21 days after the last administration of cabazitaxel).

It also tracked 6 secondary outcomes, for example Progression-Free Survival, Overall Survival, RECIST response for patients with measurable disease, Prostate-Specific Antigen response, Pain palliation in patients with a baseline pain score greater or equal to 2 and Toxicity (adverse events considered to be at least possibly drug-related).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Octreotide in 9 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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