Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)

What Was Tested

In this phase 2 trial, researchers set out to test Leuprolide.

Participants will be assessed at standard of care clinic visits every 3 months.

The follow-up period is 36 months.

It had two arms (groups): Recurrence-directed therapy (RDT) + ADT x 12 months (experimental) and Recurrence-directed therapy (RDT) alone (active comparator).

Local, regional or distant oligometastatic RDT in addition to treatment with ADT for 12 months in the form of ELIGARD®.

Local, regional, and distant oligometastatic RDT.

The registry classes the interventions as drug and radiation.

More on the Plan

Eligible and consenting patents will be randomized in a 1:1 fashion to either RDT alone (standard arm) or RDT +ADT (ELIGARD®) x12 months (experimental arm).

The follow-up period is 36 months from the date of randomization.

The planned sample size is 162 study participants.

Who Took Part

162 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: Previous biopsy-proven localized prostate adenocarcinoma (without predominant features of sarcomatoid, small cell or neuroendocrine carcinoma) treated with definitive or salvage radiotherapy ≥ 2 years or more before enrollment. Recurrent Oligo-metastatic CSPC, M0 on conventional imaging (bone scan and CT scan of chest/abdomen/pelvis) with ≤ 5 metastases cumulative on all imaging, including MRI and PSMA-PET. All sites of recurrent disease must be amenable to treatment with radiotherapy or surgery in the judgment of the investigator. Biochemical recurrent prostate cancer with ONE of the following PSA recurrence definitions:. After definitive radiotherapy (prostate in situ), with PSA ≥ nadir + 2ng/ml;.

The full record lists 6 inclusion and 10 exclusion criteria; among the exclusions: age \< 18; ECOG Performance Status ≥3; PSA ≥ 20 ng/ml.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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.

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

It started in 2026-05-06 with completion listed for 2031-04.

It ran at 5 sites in Canada (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Composite progression free survival (time frame: Time from randomization to the occurrence of composite PFS event occurring up to the 36 month follow-up).

It also tracked 8 secondary outcomes, for example Disease progression, Time to initiation of tertiary therapy;, Proportion of patients that develop castrate-resistant prostate cancer (CRPC), Overall survival, Rate of early and late Grade 3 or higher GU and GI toxicity and Quality of life assessed by EORTC QLQ C30.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 162 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.