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

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ClinicalTrials.gov Identifier: NCT03124433
Recruitment Status : Active, not recruiting
First Posted : April 21, 2017
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Lee Lui Shiong, Singapore General Hospital

Tracking Information
First Submitted Date  ICMJE April 9, 2017
First Posted Date  ICMJE April 21, 2017
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE June 20, 2017
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03124433 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2017)
  • 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
  • Proportion of tumour and benign cells with androgen receptor localisation in the cytoplasm and nucleus [ Time Frame: 16 weeks ]
    To ascertain the eAR intra-cellular localisation after neoadjuvant apalutamide therapy
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in Treatment of Intermediate to High Risk Prostate Cancer
Official Title  ICMJE Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of the Prostate
Intervention  ICMJE Drug: Apalutamide
Participants will receive oral apalutamide 240mg daily for 12 weeks
Other Name: ARN509
Study Arms  ICMJE Experimental: Neoadjuvant apalutamide
Oral apaluatmide 240mg daily for 12 weeks followed by standard of care robotic radical prostatectomy and pelvic node dissection
Intervention: Drug: Apalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 20, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2019
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages  ICMJE 21 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03124433
Other Study ID Numbers  ICMJE ARN509 - 2016
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Lee Lui Shiong, Singapore General Hospital
Study Sponsor  ICMJE Singapore General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lui Shiong Lee, MBBS,MRCS Singapore General Hospital
PRS Account Singapore General Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP