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

NCT03124433 | Completed Phase 2

• 1 other identifier: ARN509 - 2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of the Prostate

Keywords

prostate cancer; prostatectomy, retropubic; Androgen Receptor Antagonists

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Proportion of patients who report significant adverse effects after 12 weeks of neoadjuvant apalutamide

  12 weeks

• The proportion of patients with peri-operative complications following neoadjuvant apalutamide and radical prostatectomy

  24 weeks

Study Arms (1)

Neoadjuvant apalutamide

EXPERIMENTAL

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

Drug: Apalutamide

Interventions

Apalutamide DRUG

Participants will receive oral apalutamide 240mg daily for 12 weeks

Also known as: ARN509

Neoadjuvant apalutamide

Eligibility Criteria

• Age: 21 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Department of Urology

Singapore, 169608, Singapore

Location

Related Publications (2)

• Yang X, Allen JC, Aslim EJ, Tay KJ, Yuen SPJ, Kanesvaran R, Chua MLK, Chong TW, Ho SSH, Lee LS. Patient-reported outcomes of a phase II neoadjuvant apalutamide (ARN-509) and radical prostatectomy in treatment of intermediate- to high-risk prostate cancer (NEAR) trial. Int J Urol. 2022 Nov;29(11):1322-1330. doi: 10.1111/iju.14994. Epub 2022 Aug 24.

  PMID: 36000794 DERIVED

• Lee LS, Sim AYL, Ong CW, Yang X, Ng CCY, Liu W, Rajasegaran V, Lim AMS, Aslim EJ, Ngo NT, Khor LY, Kanesvaran R, Allen JCJ, Tay KJ, Yuen JSP, Chong TW, Ho SSH, Teh BT, Chua MLK. NEAR trial: A single-arm phase II trial of neoadjuvant apalutamide monotherapy and radical prostatectomy in intermediate- and high-risk prostate cancer. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):741-748. doi: 10.1038/s41391-022-00496-8. Epub 2022 Jan 28.

  PMID: 35091711 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Lui Shiong Lee, MBBS,MRCS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 21, 2017
• Study Start: June 20, 2017
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

SG (1)