NCT03124433

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Singapore General Hospital · Academic / Other
• Sex: Male
• Age: 21 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase II single arm study looking at the efficacy of 12 weeks of neoadjuvant apalutamide (ARN 509), combined with standard-of-care radical prostatectomy, for D'Amico intermediate to high risk prostate cancer patients. The phases of the study will include: screening, treatment and follow-up phases. Safety will be monitored throughout the study.

Conditions

• Cancer of the Prostate

Interventions

Type	Name	Description
DRUG	Apalutamide	Participants will receive oral apalutamide 240mg daily for 12 weeks

Timeline

• Start date: 2017-06-20
• Primary completion: 2019-08-22
• Completion: 2019-08-22
• First posted: 2017-04-21
• Last updated: 2020-03-19

Locations

1 site across 1 country: Singapore