NCT01994239

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

A Multicenter Randomised Phase II Study Comparing the Efficiency of a HT Concomitant With RT vs RT Alone in the Salvage of Patients With a Detectable PSA After Prostatectomy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Adenocarcinoma of Prostate

Interventions

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

Timeline

• Start date: 2012-12-01
• Primary completion: 2022-03-01
• Completion: 2025-03-01
• First posted: 2013-11-25
• Last updated: 2024-12-16

Locations

39 sites across 1 country: France