Degarelix Before Radical Prostatectomy

December 15, 2014 updated by: Greg Shaw, University of Cambridge

A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy

The biological effects of castration on prostate cancers will be studies by administration of degarelix prior to radical prostatectomy.

The effects will be studied by analysis of gene expression and immunohistochemistry focusing on markers of proliferation and apoptosis of samples taken at the time of radical prostatectomy (7 days after administration of degarelix).

Tumours from patients treated with neo-adjuvant degarelix will be compared with tumours from patients who have not been medically castrated.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

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

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB20QQ
        • Recruiting
        • Cambridge University Hopital NHS Trust
        • Contact:
          • Greg Shaw
        • Principal Investigator:
          • David Neal, MS FRCS

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Intermediate/high risk prostate cancer
  • Patient eligible for and wanting surgery

Exclusion Criteria:

  • Inability to consent
  • Previous thromboembolism/arrhythmias
  • contraindication to degarelix or surgery

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Degarelix treated group
240mg degarelix s.c. injection to be administered 7 days prior to radical prostatectomy for high/intermediate risk prostate cancer.
Drug: 240mg degarelix s.c. injection
7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.
Other Names:
  • medical castration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proliferative index defined by immunohistochemistry for ki67
Time Frame: at surgery, 7 days after administration of degarelix
at surgery, 7 days after administration of degarelix

Secondary Outcome Measures

Outcome Measure
Time Frame
Gene expression levels measured by microarray
Time Frame: At surgery 7 days after degarelix administration
At surgery 7 days after degarelix administration

Collaborators and Investigators

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

Sponsor

University of Cambridge

Investigators

  • Study Chair: David Neal, BSc MS FRCS, Cambridge University

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

July 1, 2011

Primary Completion (Anticipated)

July 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 6, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 15, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/H0311/2

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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