Degarelix Neo-Adjuvant Radical Prostatectomy Trial

December 21, 2015 updated by: University Health Network, Toronto

Phase II Randomized Open Label Study of Neo-Adjuvant Degarelix vs. LHRH Agonist in Prostate Cancer Patients Prior to Radical Prostatectomy

To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Vancouver General Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men >18 and =< 75 years of age
  • Willing and able to provide informed consent, either alone or with the aid of a translator
  • Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment
  • Gleason Score >= 7and/or prostate cancer that is clinical stage T2 disease.
  • Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation
  • Normal organ and marrow function as defined by the following criteria:
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

  • Previous or current use of hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti-androgens, estrogens, megestrol acetate, and ketoconazole)
  • History of receiving radiation to the pelvic area.
  • Previously received therapy with 5-alpha reductase inhibitors finasteride and/or dutasteride 4 weeks prior to randomization.
  • History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
  • History of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.
  • Known hypersensitivity towards any component of the investigational medicinal product or Casodex (bicalutamide) or their excipients.
  • Marked baseline prolongation of QT/QTcF interval (e.g. repeated demonstration of a QTcF interval >450 ms).
  • History of risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, or family history of Long QT Syndrome).
  • Previous history or presence of another malignancy, other than prostate cancer or treated squamous / basal cell carcinoma of the skin, within the last five years.
  • Clinically significant laboratory abnormalities (e.g. severe renal or hepatic impairment) which in the judgment of the Investigator would affect the patient's health or the outcome of the trial.
  • Clinically significant disorder (other than prostate cancer) including, but not limited to, renal, haematological, gastrointestinal, endocrine, cardiac, neurological, or psychiatric disease, and alcohol or drug abuse or any other condition, which may affect the patient's health or the outcome of the trial as judged by the Investigator.
  • Use of natural medicines thought to have endocrine effects on prostate cancer (e.g. saw palmetto and St. John's Wort) 4 weeks prior to randomization.
  • Mental incapacity or language barrier precluding adequate understanding or co operation.
  • Use of an investigational drug within the last 28 days preceding the Screening Visit or longer if considered to possibly influence the outcome of the current trial.
  • Previously participated in any degarelix trial.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Degarelix
Degarelix Alone
Drug: Degarelix
Experimental: Degarelix + Casodex
Degarelix and Casodex
Drug: Degarelix
Drug: Casodex
Active Comparator: LHRH Agonist + Casodex
LHRH Agonist and Casodex
Drug: LHRH Agonist
Drug: Casodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intratumoral androgen levels
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy
Time Frame: Week 12
Week 12

Other Outcome Measures

Outcome Measure
Time Frame
Serum levels of Androgen Receptor after neo-adjuvant therapy
Time Frame: Baseline, Week 12
Baseline, Week 12
Serum level of Follicle Stimulating Hormone (FSH) after neo-adjuvant therapy
Time Frame: Baseline, Week 12
Baseline, Week 12
Serum Level of Inhibin-b and GnRH after neo-adjuvant therapy
Time Frame: Baseline, Week 12
Baseline, Week 12

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

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

August 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 23, 2012

First Posted (Estimate)

August 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEG_PRE-OP_001
  • Degarelix Pre-Op

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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