Triptorelin, Flutamide, and External-Beam Radiation Therapy or External-Beam Radiation Therapy Alone in Treating Patients With Stage II or Stage III Prostate Cancer

What Was Tested

The trial (phase 3) is built around Triptorelin.

RATIONALE: Androgens can cause the growth of prostate cancer cells.

Drugs, such as triptorelin and flutamide, may stop the adrenal glands from making androgens.

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

It had two arms (groups): radiotherapy alone (active comparator) and Radiotherapy + androgene deprivation (experimental).

The registry classes the interventions as drug and radiation.

More on the Plan

OUTLINE: This is a randomized, multicenter study.

Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo conformal external beam radiotherapy. * Arm II: Patients receive androgen blockade therapy comprising triptorelin subcutaneously every 4 weeks and oral flutamide once daily.

Androgen blockade therapy continues for a total of 4 months.

Two months after initiation of androgen blockade therapy, patients undergo conformal external beam radiotherapy.

Who Took Part

The registry lists 378 actual participants took part.

It was open to men only aged from 0 years up to 74 years.

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

Examples of who could join: Histologically confirmed prostate cancer, meeting the following clinical staging criteria:. Stage T1b-T1c AND prostate specific antigen (PSA) ≥ 10 ng/mL OR Stage T1b-T1c AND Gleason score ≥ 7 OR Stage T2a-T3a. No lymph node invasion (N0 or N-). No metastatic disease (M0) by thoracic radiography and bone scan. PSA \< 30 ng/mL.

The full record lists 19 inclusion and 0 exclusion criteria.

How the Study Was Run

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

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

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

Nothing was hidden in this open-label Triptorelin study: the participants and staff both knew the treatment.

It started in 2003-09-10 with completion listed for 2015-10.

It ran at 31 sites in France (31).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Impact of complete androgen blockade for 4 months. Survival, in terms of clinical or biological remission, at 5 years. Overall survival.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 378 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.