NCT01780220

Radiotherapy Plus Hormone Therapy in Biochemically-relapsing Prostate Cancer Patients Following Surgery

Safety and Efficacy of Radiotherapy Combined With a 6-month LH-RH Agonist and Abiraterone Hormone Therapy Treatment in Biochemically-relapsing Prostate Cancer Following Surgery

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

As there is no prospective data on the combination of abiraterone and salvage radiotherapy, the aim of this study is to further evaluate the safety profile of abiraterone acetate plus prednisone in patients with prostate cancer who are biochemically relapsing after surgery and undergo salvage radiotherapy with 6-months LH-RH agonist. The investigators hypothesize that the toxicity profile of both treatments should not potentiate each other. This study will also provide preliminary data on the efficacy of this combination.

Conditions

• Biochemically-relapsing Prostate Adenocarcinoma Following Radical Prostatectomy

Interventions

Type	Name	Description
DRUG	Abiraterone	Abiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy

Timeline

• Start date: 2012-12-01
• Primary completion: 2022-01-07
• Completion: 2022-01-07
• First posted: 2013-01-30
• Last updated: 2022-05-19

Locations

5 sites across 1 country: France