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

Cancer of the Prostate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124433
• Other study ID #: ARN509 - 2016
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2017
• Est. completion date: August 22, 2019

Study information

• Verified date: March 2020
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cancer of the Prostate
• Prostatic Neoplasms

Intervention

Drug:
• Apalutamide
Participants will receive oral apalutamide 240mg daily for 12 weeks

Locations

Country	Name	City	State
Singapore	Department of Urology	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy	This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy	24 weeks
Primary	Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy	Patients who attain serum PSA levels below 0.03microg/L	24 weeks
Secondary	Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide	Adverse effects as defined by CTCAE criteria grade 3 and above	12 weeks
Secondary	The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy	The level of complications defined by Clavien-Dindo classification	24 weeks