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Degarelix Before Radical Prostatectomy

Sponsor
University of Cambridge (Other)
Overall Status
Unknown status
CT.gov ID
NCT01852864
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
53
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 240mg degarelix s.c. injection
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy
Study Start Date :
Jul 1, 2011
Anticipated Primary Completion Date :
Jul 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. proliferative index defined by immunohistochemistry for ki67 [at surgery, 7 days after administration of degarelix]

    Secondary Outcome Measures

    1. Gene expression levels measured by microarray [At surgery 7 days after degarelix administration]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cambridge University Hopital NHS Trust Cambridge Cambridgeshire United Kingdom CB20QQ

    Sponsors and Collaborators

    • University of Cambridge

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Greg Shaw, Clinical Lecturer in Urology, University of Cambridge
    ClinicalTrials.gov Identifier:
    NCT01852864
    Other Study ID Numbers:
    • 11/H0311/2
    First Posted:
    May 14, 2013
    Last Update Posted:
    Dec 16, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Greg Shaw, Clinical Lecturer in Urology, University of Cambridge
    Prostate cancer
    testosterone
    castration
    degarelix
    proliferation
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Dec 16, 2014