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NCT Number: NCT03124433

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

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.

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Key information

Conditions

Cancer of the Prostate Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

21 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Urology

Singapore, 169608

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apalutamide

Drug

Participants will receive oral apalutamide 240mg daily for 12 weeks

Other names: ARN509

Primary outcomes

  1. Proportion of patients with pathological downstaging after neodjuvant apalutamide followed by radical prostatectomy

    Time frame: 24 weeks

    This is described as residual cancer burden and treatment response group on histopathology after neoadjuvant apalutamide and radical prostatectomy

  2. Proportion of patients with biochemical treatment response following neoadjuvant apalutamide and radical prostatectomy

    Time frame: 24 weeks

    Patients who attain serum PSA levels below 0.03microg/L

Secondary outcomes

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

    Time frame: 12 weeks

    Adverse effects as defined by CTCAE criteria grade 3 and above

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

    Time frame: 24 weeks

    The level of complications defined by Clavien-Dindo classification

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 21, 2017
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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