Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

What Was Tested

The trial (phase 2) is built around Degarelix.

It had two arms (groups): Group 1: Radiation Therapy Only (active comparator) and Group 2: Radiation Therapy + darolutamide + degarelix (experimental).

Participants randomized to Group 1 will receive radiation therapy only.

Participants randomized to Group 2 will receive radiation therapy only + darolutamide + degarelix.

The registry classes the interventions as drug and radiation.

Who Took Part

Enrollment: 208 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: Male ≥ 18 years of age;. PSA measurement performed within 60 days prior to consent;. UIR-PCa, at least one of the following:. 2 or 3 NCCN IR-PCa criteria;. Gleason score 4+3;.

The full record lists 12 inclusion and 20 exclusion criteria; among the exclusions: currently taking medications that might cause toxicity if combined with darolutamide (see section 4.6);; platelet count \< 100,000 × 109/μl, independent of transfusion and/or growth factors, within 90 days prior to consent;; abnormal renal function, assessed within 90 days prior to consent:.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Degarelix group and the comparison group should start out alike.

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

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

It started in 2024-07-02 with completion listed for 2028-12.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Recurrence Free Survival (time frame: Recurrence Free Survival will be monitored for a duration of 5 years).

It also tracked 8 secondary outcomes, for example Difference in RFS rates (as defined in primary outcome measure) between IDC/SChLAP1 and treatment groups, Testosterone levels and Rate of maximal biochemical control, defined as 2 consecutive undetectable PSA (<0.05 ng/mL) during follow-up.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 208 people.

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

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