Triptorelin and Radiation Therapy in Treating Patients Who Have Undergone Surgery for Intermediate-Risk Stage III or Stage IV Prostate Cancer

What Was Tested

This registered phase 3 trial tested Triptorelin.

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

Antihormone therapy, such as triptorelin, may lessen the amount of androgens made by the body.

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

It had two arms (groups): A Relapse (other) and B Immediate treatment (experimental).

Radiotherapy and Hormonotherapy only if relapse.

Radiotherapy and Hormonotherapy at randomization.

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

More on the Plan

OUTLINE: Patients are randomized to 1 of 2 treatment arms. * Arm I (delayed treatment): Patients receive triptorelin intramuscularly on day 1 and then 3 months later.

Patients also undergo conformal radiotherapy daily, 5 days a week, for 7 weeks.

Treatment begins at biochemical relapse (PSA is more than 0.2 ng/mL) and before PSA is more than 2 ng/mL. * Arm II (immediate treatment): Patients receive treatment as in arm I, but treatment begins within 6 months after surgery.

After completion of study treatment, patients are followed for up to 5 years.

Who Took Part

424 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

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

Examples of who could join: Patient must have undergone curative surgery for a localized adenocarcinoma of the prostate. PT3a, pT3b (or pT4 by reaching the bladder neck), or R1 disease (stage III or IV). PSA ≤0.1 ng/mL after prostatectomy (confirmed at 1 month). May receive treatment within 6 months after surgery. Positive margins (tumoral glands in contact with contour ink) on the surgical specimen.

The full record lists 11 inclusion and 14 exclusion criteria; among the exclusions: patient with prostate cancer other than adenocarcinoma; gleason score ≥8 and with seminal vesicles involved; pn1 disease (histologically confirmed nodal invasion during initial lymph node resection).

How the Study Was Run

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

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

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

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

It started in 2008-04-07 with completion listed for 2020-04.

It ran at 17 sites in France (17).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Event-free survival.

It also tracked 6 secondary outcomes, for example Overall survival, Metastases-free survival, Acute or chronic toxicity, Quality of life questionnaire - Core 30 (QLQ-C30), Quality of Life Questionnaire - Prostate Cancer Module (QLQ-PR25) and Functional dependence in patients over 75 years old.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 424 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.