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.
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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