Optimal Duration of Hormonal Therapy for Unfavorable Intermediate-risk Prostate Cancer Patients: 6 Versus 12 Months.

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

Patients with unfavorable intermediate-risk prostate cancer will be randomized between 6 versus 12 months of hormone therapy with radiation therapy.

It had two arms (groups): 6 months of hormone therapy (active comparator) and 12 months of hormone therapy (experimental).

Patients will receive a total of two 3-month injections of a LHRH agonist.

Patients will receive a total of four 3-month injections of a LHRH agonist.

The registry classes the interventions as drug and radiation.

More on the Plan

A total of 400 patients with unfavorable intermediate-risk prostate cancer will be randomized into 2 arms: The first arm will receive the standard 6-month duration of hormone therapy with concomitant radiation therapy.

The second arm will receive 12 months with concomitant radiation therapy.

The choice of radiation treatment will be to the investigator's discretion..Patients will be stratified according to the number of intermediate-risk factors and according to the radiation therapy type.

Who Took Part

400 planned participants were the target.

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: 1\. Histologically confirmed adenocarcinoma of the prostate diagnosed within 6 months prior to randomization, (if longer than 6 months, needs to be approved by the central Principal Investigator). ≥ 2 of the following:. Gleason score 7 (3+4) or (4+3). PSA 10-20 ng/mL. Gleason Score 7 (4+3).

The full record lists 11 inclusion and 1 exclusion criteria.

How the Study Was Run

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

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

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

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

It started in 2025-03 with completion listed for 2033-03.

It ran at 5 sites in Canada (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: biochemical progression-free survival (time frame: 5 years).

It also tracked 4 secondary outcomes, for example overall survival, biochemical progression-free survival, disease-specific survival and CTCAE version 5 acute and late toxicity.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 400 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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