Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 90 of 103 for:    "Kennedy disease"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03124433
Recruitment Status : Recruiting
First Posted : April 21, 2017
Last Update Posted : August 15, 2017
Sponsor:
Information provided by (Responsible Party):
Lee Lui Shiong, Singapore General Hospital

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.


Condition or disease Intervention/treatment Phase
Cancer of the Prostate Drug: Apalutamide Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Apalutamide (ARN509) and Radical Prostatectomy in the Treatment of Intermediate to High Risk Prostate Cancer
Actual Study Start Date : June 20, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Apalutamide

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 Name: ARN509




Primary Outcome Measures :
  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 Outcome Measures :
  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. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124433


Contacts
Layout table for location contacts
Contact: Cally Soon +65 6323 7532 cally.soon@singhealth.com.sg

Locations
Layout table for location information
Singapore
Department of Urology Recruiting
Singapore, Singapore, 169608
Contact: Lui Shiong Lee, MRCS    +65-63214056    lee.lui.shiong@singhealth.com.sg   
Contact: Cally Soon    +65-6323 7532    cally.soon@singhealth.com.sg   
Sponsors and Collaborators
Singapore General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Lui Shiong Lee, MBBS,MRCS Singapore General Hospital

Layout table for additonal information
Responsible Party: Lee Lui Shiong, Urologist, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03124433     History of Changes
Other Study ID Numbers: ARN509 - 2016
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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

Keywords provided by Lee Lui Shiong, Singapore General Hospital:
prostate cancer
prostatectomy, retropubic
Androgen Receptor Antagonists

Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases