Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With 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 damage tumor cells.

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

More on the Plan

OUTLINE: This is a randomized, multicenter study.

Patients are stratified according to tumor class (T1b-c vs T2a), initial prostate-specific antigen level (10 ng/mL vs 10-20 ng/mL vs greater than 20 ng/mL), Gleason score (2-6 vs 7-10) and participating center.

Beginning on day 8, patients undergo radiotherapy as in arm I.

Quality of life is assessed at baseline and then at months 6, 12, 24, and 36.

Who Took Part

819 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: T1b-c, N0, M0 with prostate-specific antigen (PSA) at least 10 ng/mL and/or Gleason score at least 7 (UICC 1997 classification) OR. T2a, N0, M0 (UICC 1997 classification). Serum PSA no greater than 50 ng/mL. No involvement of pelvic lymph nodes. 80 and under.

The full record lists 18 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized.

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

It started in 2001-04 with completion listed for 2008-04.

It ran at 20 sites in France (5), Belgium (3), Netherlands (3), Italy (2), Cyprus (1) and Czechia (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Biochemical and clinical disease-free survival as measured by Logrank prostate-specific antigen progression every 6 months until year 5, and annually thereafter.

It also tracked 6 secondary outcomes, for example Clinical disease-free survival as measured by Logrank every 6 months until year 5, and annually thereafter, Overall survival as measured by Logrank every 6 months until year 5, and annually thereafter, Local control as measured by Gray scale every 6 months until year 5, and annually thereafter and Acute toxicity as measured by NCI-CTC v2.0 up to 1 month post radiotherapy.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Goserelin in 819 people.

With 819 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.