Radiation Therapy With or Without Goserelin in Treating Patients Who Have Undergone Surgery for Recurrent or Refractory Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Goserelin.

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

Androgens can cause the growth of prostate cancer cells.

Antihormone therapy, such as goserelin, may stop the adrenal glands from making androgens.

It had two arms (groups): I (active comparator) and II (experimental).

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

More on the Plan

OUTLINE: This is an open-label, randomized, parallel-group, multicenter study.

Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo radiotherapy once daily, 5 days a week, for 7 weeks. * Arm II: Patients undergo radiotherapy as in arm I.

Patients also receive goserelin subcutaneously on day 1 and again 3 months later.

Quality of life is assessed periodically.

Who Took Part

The registry lists 743 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. Localized disease treated with surgery only. PT2, pT3, or pT4. PN0 or pNx. No clinical signs of progressive disease.

The full record lists 20 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this Goserelin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2006-10 with completion listed for 2015-03.

It ran at 31 sites in France (31).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Progression-free (biological and/or clinical) survival (time frame: 3.5 years).

It also tracked 6 secondary outcomes, for example Overall survival, Metastases-free survival, Immediate and delayed toxicities, Delay in reaching the prostate-specific antigen nadir, Quality of life at 1 and 5 years after radiotherapy and Functional dependence at 1 and 5 years after radiotherapy in patients age 75 years and over.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 743 people.

With 743 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.