Sbrt±sTad for Unfavorable iNtermediate rIsk/High Risk Prostate caNcer

What Was Tested

The trial (phase 2) is built around Triptorelin.

This is a prospective, open, randomized phase II trial.

It had two arms (groups): arm 1 (no intervention) and arm 2 (experimental).

SBRT alone 38 GY in 4 fractions.

SBRT along with short course (6 months) androgen deprivation (STAD).

The registry classes the interventions as drug.

More on the Plan

Patients will be randomized between SBRT alone (38 Gy in 4 fractions) or SBRT (same schedule) along with short course (6 months) androgen deprivation (STAD).

All patients will be treated by intensity modulated radiotherapy.

Regarding the combined modality approach, SBRT has to start within 3 months from the first injection of LHRH analogue.

Who Took Part

Enrollment: 146 planned participants were the target.

It was open to men only aged from 18 years up to 90 years.

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

Examples of who could join: Histologically proven prostate adenocarcinoma. IR or HR in the NCCN definition. N0M0 at staging with choline or (preferably) PSMA PET-CT;. ECOG performance status between 0 and 2;.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: previous local treatment of the prostate with surgery (radical prostatectomy or cryotherapy); previous radiotherapy to the pelvis; previous chemotherapy for malignancy in past 5 years.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

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.

Only one side, usually the participants, was kept unaware of whether Triptorelin was given.

Those kept unaware of assignments: investigator.

It started in 2021-02-02 with completion listed for 2024-02-02.

It ran at 3 sites in Italy (3).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: 3-yr bNED survival (time frame: 3 years).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 146 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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