Radiation Therapy and Hormone Therapy in Treating Patients With Prostate Cancer

What Was Tested

The trial (phase 3) is built around Goserelin.

It had four arms (groups): Arm 1 (experimental), Arm 2 (experimental), Arm 3 (experimental) and Arm 4 (experimental).

Neoadjuvant TAS given 2 months before and during RT to the prostate only.

RT to the whole pelvis followed by a boost to the prostate followed by 4 months of TAS.

The registry classes the interventions as drug and radiation.

More on the Plan

Compare treatments with regard to local control, time to distant failure, and overall survival.

PROJECTED ACCRUAL: 1,200 patients will be accrued over 2.5 years.

Who Took Part

The registry lists 1322 actual participants took part.

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

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

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

The Goserelin group and the comparison group ran side by side rather than switching.

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

It started in 1995-04 with completion listed for 2001-04.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Progression-free survival (Arms 1, 3 vs. Arms 2, 4).

It also tracked 4 secondary outcomes, for example Progression-free survival (Arms 1, 2 vs. Arms 3, 4), Local progression, Distant metastasis and Overall survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 1322 people.

With 1322 participants it is a large trial for this field.

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.