A Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin [amount hidden] Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients.

What Was Tested

In this phase 4 trial, researchers set out to test Triptorelin.

To reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin.

Both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months.

It had two arms (groups): one (active comparator) and Active surveillance (no intervention).

Triptorelin, powder and solvent for suspension (prolonged released form).

Active surveillance after radical prostatectomy (RP).

The registry classes the interventions as drug.

More on the Plan

This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.

Who Took Part

The registry lists 226 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: Histopathologically confirmed adenocarcinoma of the prostate. Radical Prostatectomy with curative intent performed no more than 8 weeks before randomisation. High risk criteria of disease progression, defined as follows:. Post-RP PSA levels ≤0.2 ng/mL at 6 weeks.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: evidence of lymph nodes or distant metastasis; positive margins; evidence of any other malignant disease, not treated with a curative intent.

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 Triptorelin group and the comparison group should start out alike.

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

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

It started in 2012-12-11 with completion listed for 2019-09-09.

It ran at 18 sites in China (9) and Russia (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Subjects With BR Events. Median Time to BRFS. Q1 Time to BRFS.

It also tracked 11 secondary outcomes, for example Median Time to Event-Free Survival (EFS), Q1 Time to EFS, Median Time to Overall Survival (OS), Q1 Time to OS, Time to Disease-specific Mortality and Median Time to PSA Doubling Time (PSADT).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Triptorelin in 226 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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