Everolimus, Bicalutamide, and Leuprolide Acetate in Treating Patients Undergoing Radiation Therapy For High-Risk Locally Advanced Prostate Cancer

What Was Tested

The trial (phase 1) is built around Leuprolide.

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Antihormone therapy, such as bicalutamide and leuprolide acetate may lessen the amount of androgens made by the body.

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

Everolimus + radiation.

The registry classes the interventions as drug and radiation.

More on the Plan

Secondary * To assess the biochemical-free survival of these patients. * To assess metastasis-free survival of these patients. * To assess the overall survival of these patients. * To assess the molecular characteristics of the tumor before treatment and correlate with outcomes.

Patients undergo radiotherapy to the prostate and seminal vesicles once daily, 5 days a week, for 7.5 weeks.

Beginning the week before radiotherapy, patients receive oral bicalutamide once daily for 1 month and oral everolimus twice daily for 8.5 weeks.

Beginning on the first week of radiotherapy, patients receive leuprolide acetate subcutaneously every 3 months for 2 years.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to men only aged up to 80 years.

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

Examples of who could join: Clinical stage ≥ T3. Gleason score ≥ 8. PSA ≥ 20 ng/mL. Previously untreated disease. Non-metastatic disease as assessed by bone scan and CT scan of the thorax and abdomen.

The full record lists 29 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Leuprolide 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 2009-01 with completion listed for 2012-12.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Acute and late toxicities (time frame: 1 year).

It also tracked 4 secondary outcomes, for example Biochemical-free survival, Metastasis-free survival, Overall survival and Pre-treatment molecular characteristics of the tumor and its correlation with outcomes.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Leuprolide in 30 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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