Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer
- Registration Number
- NCT03124433
- Lead Sponsor
- Singapore General Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 30
- histologically diagnosed primary adenocarcinoma of the prostate gland
- non-metastatic D'Amico intermediate to high risk patients undergoing radical prostatectomy as primary definitive therapy
- no known hypersensitivity to the study drug
- able to swallow study drug as whole tablets
- presence of small cell, neuroendocrine or ductal differentiation at needle biopsy
- individuals with prior pelvic irradiation therapy for any form of pelvic malignancy
- patients with psychiatric conditions requiring anti-psychotic therapy, or preventing the provision of informed consent
- renal impairment with serum creatinine more than twice the upper limit of normal
- Other prior malignancy less than or equal to 5 years prior to recruitment
- ECOG performance status 2 or poorer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Neoadjuvant apalutamide Apalutamide Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection
- Primary Outcome Measures
Name Time Method Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy 24 weeks This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy
Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy 24 weeks Patients who attain serum PSA levels below 0.03microg/L
- Secondary Outcome Measures
Name Time Method Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide 12 weeks Adverse effects as defined by CTCAE criteria grade 3 and above
The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy 24 weeks The level of complications defined by Clavien-Dindo classification
Trial Locations
- Locations (1)
Department of Urology
🇸🇬Singapore, Singapore