Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.

It had two arms (groups): IMRT alone to 86.4 Gy (experimental) and IMRT TO 75.6 Gy plus Adjuvant Androgen Deprivation (experimental).

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

More on the Plan

OUTLINE: This is a randomized study.

Patients are stratified according to prostate-specific antigen level, Gleason score, and clinical stage.

Three to seven days after the initiation of bicalutamide, patients also receive goserelin subcutaneously monthly for 2 years.

Patients discontinue bicalutamide on or near the end of radiotherapy.

Who Took Part

The registry lists 3 actual participants took part.

It was open to men only aged from 18 years up to 120 years.

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

Examples of who could join: Histologically confirmed adenocarcinoma of the prostate. Unfavorable-risk disease, including at least 2 of the following characteristics:. Prostate-specific antigen level greater than 10 ng/mL. Gleason score greater than 7. Intermediate-risk disease with a Gleason score of at least 8 allowed.

The full record lists 28 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Goserelin study did not mask who received what.

It started in 2003-05 with completion listed for 2004-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: compare the quality of life (time frame: 2 years).

It also tracked 2 secondary outcomes, for example response and toxicity.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 3 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 Goserelin compound page, all human trials.