Impact of Hormonal Therapy on Prostate Cancer Recurrence After Radical Prostatectomy

What Was Tested

The trial (phase 3) is built around Leuprolide.

Prostate cancer is the most common cancer in men and radical prostatectomy is the most frequent treatment for this disease.

Salvage radiation after recurrence is successful in less than half of these men and most of those die from their disease.

It had two arms (groups): Standard of Care (no intervention) and Standard of Care plus Androgen Deprivation Therapy (Lupron Depot) (experimental).

Standard of Care.

The registry classes the interventions as drug.

Who Took Part

The registry lists 72 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: Undetectable PSA (\<0.02 ng/ml) within 16 weeks post-operative;.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: unwilling to receive adt;; previously received adt;; lymph node metastases.

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 Leuprolide group and the comparison group should start out alike.

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

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

It started in 2023-03-06 with completion listed for 2026-11.

It ran at 3 sites in Canada (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Rate of enrolment (time frame: 1 year).

It also tracked 4 secondary outcomes, for example Rate of enrolment per site, Proportion of patients completing study intervention per-protocol, Time to study start-up and Completeness of study assessments.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 72 people.

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

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