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Clinical Trial Summary

This is a multicenter, randomized, open label, phase III study comparing the efficacy and safety of apatulamide combined with concomitant prostate-bed salvage radiotherapy (SRT) and androgen deprivation therapy (ADT) versus concomitant prostate-bed SRT and ADT in high-risk postprostatectomy biochemically relapsed prostate cancer patients.


Clinical Trial Description

The purpose of the CARLHA-2 study is to determine if the combination of apalutamide with 6 months of LHRH agonists and radiotherapy results in an improvement of progression-free survival (PFS) in comparison to the combination of 6 months of LHRH agonists with radiotherapy in high-risk postprostatectomy biochemically relapsed prostate cancer patients. Radical prostatectomy must have been done at least 6 months before inclusion and is not part of this study. Patients after radical prostatectomy and biochemical relapse will be randomized in a 1:1 ratio to receive either 6 months of LHRH agonists + SRT or 6 months of LHRH agonists + SRT + 6 months of apalutamide. The stratification variables include Gleason score, prostate-specific antigen (PSA), negative resection margins, extension to seminal vesicle(s), and PSA doubling time. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04181203
Study type Interventional
Source UNICANCER
Contact UNICANCER
Phone +33 (0) 1 44 23 04 04
Email getug-afu33@unicancer.fr
Status Recruiting
Phase Phase 3
Start date January 9, 2020
Completion date December 28, 2033

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