Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer

Sponsor
Singapore General Hospital
Study ID
NCT03124433
Phase
PHASE2
Status
Completed

Conditions

  • Cancer of the Prostate

Eligibility Criteria

Sex
MALE
Age
21 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    Participants will receive oral apalutamide 240mg daily for 12 weeks

Study Details

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.

Key Dates

Start date
Jun 20, 2017
Status verified
Mar 2020
Primary completion
Aug 22, 2019
Completion
Aug 22, 2019

Study Design

Enrollment
30 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant apalutamide
    Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection

Primary Outcome Measure

Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy [ Time Frame: 24 weeks ]

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