Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Pasireotide.

Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Pasireotide may inhibit the secretion of hormones.

It had 1 arm (groups): Treatment (chemotherapy, receptor agonist) (experimental).

The registry classes the interventions as drug.

More on the Plan

To assess the pretherapy circulating tumor cell (CTC) counts and change in CTC after therapy, and to associate them with TTP and OS.

Patients receive pasireotide intramuscularly (IM) on day 1, docetaxel intravenously (IV) over 1 hour, and prednisone orally (PO) twice daily (BID) continuously.

Courses with docetaxel repeat every 21 days and courses with pasireotide repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 28 days and then every 3 months thereafter.

Who Took Part

Enrollment: 18 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: Eastern Cooperative Oncology Group (ECOG) performance status =\< 2. Life expectancy 12 weeks or more. Absolute neutrophil (ANC) \>= 1.5 x 10\^9/L. Platelets \>= 100 x 10\^9/L. Serum bilirubin =\< 2 x upper limit of normal (ULN).

The full record lists 14 inclusion and 25 exclusion criteria; among the exclusions: prior treatment with any cytotoxic chemotherapy, radiation, immunotherapy, or any investigational drug within the preceding 4 weeks; patients who have undergone major surgery within 4 weeks prior to study enrollment; chronic treatment with immunosuppressive agents except steroids.

How the Study Was Run

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

Everyone knew when Pasireotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2011-10 with completion listed for 2017-07-20.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example The Number of Patients With Toxicity as Assessed Via NCI CTCAE Version 4.0, Percentage Prostate-specific Antigen (PSA) Change Noted, Time to Progression (TTP), Overall Survival (OS) and Measurements of CTC Counts, the Change Between Time-points Pre-therapy, Post-therapy.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Pasireotide in 18 people.

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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