Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy

What Was Tested

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

It had two arms (groups): Radiation (active comparator) and Radiation and Degarelix (experimental).

Pelvic radiotherapy * 46 Gy in 23 fractions of 2 Gy. * prostate only-boost up to 66 Gy.

The registry classes the interventions as drug and radiation.

More on the Plan

Patients will be treated according to the following scheme: * Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy * Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months.

Who Took Part

Enrollment: 120 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: Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage). R0 or R1. PN0 or pNx. PSA ≤2 ng/mL at moment of the randomisation. No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0.

The full record lists 16 inclusion and 16 exclusion criteria; among the exclusions: prostate cancer histology other than adenocarcinoma; patients pn1, n1 and m1; history of pelvic radiotherapy.

How the Study Was Run

Design: 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 2012-12 with completion listed for 2022-03.

It ran at 39 sites in France (39).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 8 secondary outcomes, for example Survival without biological event, Survival without clinical event, Survival without metastases, Overall survival, Acute and late toxicities of the association of hormone therapy with radiotherapy and Toxicities of radiotherapy.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 120 people.

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

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