Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer
Status:
Completed
Trial end date:
2019-08-22
Target enrollment:
Participant gender:
Summary
This is an investigator-initiated phase II single arm trial, combining neoadjuvant
apalutamide (ARN509) with radical prostatectomy, in the treatment of D'Amico intermediate to
high risk organ-confined prostate cancer. Apalutamide has shown efficacy in castrate
resistant prostate cancer in phase II studies and are now in phase III trials combined with
radiation in organ confined disease.
The primary study objectives include assessment of (i) oncological efficacy as determined by
tumour downstaging and achievement of nadir PSA The secondary study objectives include(i)
determination of adverse effects related to apalutamide and surgical complication rates (ii)
human prostate tissue effect of apalutamide
The study will recruit thirty eligible participants who will receive 12 weeks of oral
apalutamide 240mg daily. This will be followed by standard-of-care radical prostatectomy. The
total trial duration is 26 weeks.