SRT Versus SRT+ADT in Prostate Cancer

What Was Tested

This registered phase 3 trial tested Triptorelin.

To clarify the role of short-term Androgen deprivation therapy (ADT) in the context of intermediate unfavorable and a subclass of high-risk patients treated with prostate Stereotactic radiotherapy (SRT).

In high risk disease, results of the combination therapy are even more clear.

It had two arms (groups): SRT+ADT (experimental) and SRT alone (no intervention).

The registry classes the interventions as drug.

Who Took Part

310 planned participants were the target.

It was open to men only aged from 18 years up to 80 years.

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

Examples of who could join: Histological confirmation of prostate acinar adenocarcinoma with a minimum of 10 biopsy cores taken. Prostate protocol MRI for local staging. Patients belonging to intermediate unfavorable group according to the D'Amico/NCCN risk group classification:. -Grade group 3 or/and. -2-3 risk factors for intermediate category (PSA 10-20 ng/ml/ Grade group 2-3/ cT2b cT2c) or/and.

The full record lists 18 inclusion and 14 exclusion criteria; among the exclusions: previous prostate surgery other than turp (at least 6 weeks prior to start of sbrt); previous pelvic rt; any prior active treatment for prostate cancer; patients on previous active surveillance are eligible if inclusion criteria are met.

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.

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

Being open-label, the Triptorelin study did not mask who received what.

It started in 2021-09-30 with completion listed for 2025-12-01.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: biochemical disease free survival (time frame: outcome will be evaluated at the completion of 5 years of follow-up).

It also tracked 11 secondary outcomes, for example Disease free survival, freedom from local recurrence, freedom from regional recurrence, freedom from distant metastasis, Overall survival and quality of life, prostate related quality of life in prostate cancer.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Triptorelin in 310 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.