Degarelix Acetate Before and During Radiation Therapy in Treating Patients With Prostate Cancer

What Was Tested

In this not phased trial, researchers set out to test Degarelix.

Drugs, such as degarelix acetate, may lessen the amount of androgens made by the body.

It had 1 arm (groups): Treatment (degarelix acetate, EBRT) (experimental).

Patients receive degarelix acetate SC on day 1. Treatment repeats every 4 weeks for up to 6 courses. Beginning at week 15, patients also undergo standard EBRT for 8.5 weeks.

The registry classes the interventions as drug, other and radiation.

More on the Plan

To evaluate the effect of neoadjuvant degarelix (degarelix acetate) on prostate dihydrotestosterone (DHT) and testosterone levels.

To determine the effect of degarelix acetate on androgen-regulated gene expression and apoptosis as assessed by immunohistochemistry, complementary deoxyribonucleic acid (cDNA) microarray analysis and reverse transcriptase (RT)-polymerase chain reaction (PCR).

OUTLINE: Patients receive degarelix acetate subcutaneously (SC) on day 1.

Treatment repeats every 4 weeks for up to 6 courses.

Who Took Part

Enrollment: 16 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: Willing and able to provide written informed consent. Written authorization for use and release of health and research study information has been obtained. Histologically proven adenocarcinoma of the prostate. Patients must be candidates for short or long term androgen deprivation in combination with external beam radiation therapy (RT) based on the following criteria:. Intermediate risk disease: T2b/c, or Gleason 7, or prostate-specific antigen (PSA) 10-20.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: patients may not be receiving any investigational agents; patients who are currently receiving active therapy for other neoplastic disorders will not be eligible; patients with histologic evidence of small cell carcinoma of the prostate will not be eligible.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Degarelix 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 2013-05 with completion listed for 2016-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Tissue Levels of DHT in Prostate Tissue as Measured by Mass Spectometry (time frame: At week 24). Tissue Levels of Testosterone in Prostate Tissue as Measured by Mass Spectometry (time frame: At week 24).

What This Means in Plain Language

Put simply, this is a not phased trial of Degarelix in 16 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 Degarelix compound page, all human trials.