Safety Study of Sorafenib With Androgen Deprivation and Radiotherapy to Treat Prostate Cancer

What Was Tested

The trial (phase 1, phase 2) is built around Leuprolide.

The purpose of this study is to evaluate the safety of a new drug- sorafenib, which is to be administered at the same time as standard treatment, which includes hormonal therapy and external beam radiotherapy.

It had 1 arm (groups): Androgen Depr, Radiotherapy, Sorafenib (experimental).

Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.

The registry classes the interventions as drug.

More on the Plan

Intensity modulated external beam radiotherapy is a standard treatment for localized prostate cancer.

This drug is approved by the FDA for treatment kidney and liver cancer.

Who Took Part

4 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 \> 18 years. Life expectancy of greater than 5 years. Patients must have normal organ and marrow function. No pelvic lymph node metastases based on pelvic CT scan or MRI. No bone metastasis. A whole body bone scan is required to rule out metastatic disease.

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: any previous, radiotherapy, or chemotherapy, or more than 4 weeks of androgen deprivation hormonal therapy for the treatment of prostate adenocarcinoma; patients may not be receiving any other investigational agents; history of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib or other agents used in this study.

How the Study Was Run

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

Being open-label, the Leuprolide 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 2008-09 with completion listed for 2013-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Biochemical Disease-free Survival.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Leuprolide in 4 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 Leuprolide compound page, all human trials.