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

March 17, 2020 updated by: Singapore General Hospital

Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant apalutamide
Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection
Drug: Apalutamide
Participants will receive oral apalutamide 240mg daily for 12 weeks
Other Names:
  • ARN509

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 weeks
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Singapore General Hospital

Investigators

  • Principal Investigator: Lui Shiong Lee, MBBS,MRCS, Singapore General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2017

Primary Completion (Actual)

August 22, 2019

Study Completion (Actual)

August 22, 2019

Study Registration Dates

First Submitted

April 9, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2020

Last Update Submitted That Met QC Criteria

March 17, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARN509 - 2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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