Back to resultsDegarelix Before Radical Prostatectomy
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
240mg degarelix s.c. injection
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer focused on measuring Prostate cancer, testosterone, castration, degarelix, proliferation
Eligibility Criteria
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
Sites / Locations
- Cambridge University Hopital NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Degarelix treated group
Arm Description
240mg degarelix s.c. injection to be administered 7 days prior to radical prostatectomy for high/intermediate risk prostate cancer.
Outcomes
Primary Outcome Measures
proliferative index defined by immunohistochemistry for ki67
Secondary Outcome Measures
Gene expression levels measured by microarray
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01852864
Brief Title
Degarelix Before Radical Prostatectomy
Official Title
A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cambridge
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, testosterone, castration, degarelix, proliferation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Degarelix treated group
Arm Type
Experimental
Arm Description
240mg degarelix s.c. injection to be administered 7 days prior to radical prostatectomy for high/intermediate risk prostate cancer.
Intervention Type
Drug
Intervention Name(s)
240mg degarelix s.c. injection
Other Intervention Name(s)
medical castration
Intervention Description
7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.
Primary Outcome Measure Information:
Title
proliferative index defined by immunohistochemistry for ki67
Time Frame
at surgery, 7 days after administration of degarelix
Secondary Outcome Measure Information:
Title
Gene expression levels measured by microarray
Time Frame
At surgery 7 days after degarelix administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Greg Shaw, MBBS MD FRCS
Phone
01223 331940
Email
greg.shaw@cruk.cam.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Marie Corcoran
Phone
01223348441
Email
marie.corcoran@addenbrookes.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Neal, BSc MS FRCS
Organizational Affiliation
Cambridge University
Official's Role
Study Chair
Facility Information:
Facility Name
Cambridge University Hopital NHS Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB20QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greg Shaw
First Name & Middle Initial & Last Name & Degree
David Neal, MS FRCS
12. IPD Sharing Statement
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Degarelix Before Radical Prostatectomy
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