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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Active Not Recruiting PHASE2 INTERVENTIONAL NCT01994239

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.

Detailed Description

Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy. 122 patients should be included over a period of 2 years. 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

Interventions

Name: Degarelix
Type: DRUG
Description: First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
Name: Pelvic Radiotherapy
Type: RADIATION
Description: 46 Gy in 23 fractions Prostate only-boost up to 66 Gy

Primary Outcomes

Measure: The efficacy of the combination of hormonal therapy by degarelix and radiotherapy on event-free survival
TimeFrame: 5 years
Description:

Trial Information

NCT ID

NCT01994239

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

UNICANCER

Last Updated

December 15, 2025