A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy
Phase 0
18 Years
80 Years
18 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer
Male
Prostate Cancer
Trial Information
A Study of the Early Biological Effects of Testosterone Suppression in Prostate Cancer Using Neoadjuvant Degarelix Prior to Radical Prostatectomy
Inclusion Criteria:
- Intermediate/high risk prostate cancer
- Patient eligible for and wanting surgery
Exclusion Criteria:
- Inability to consent
- Previous thromboembolism/arrhythymias
- contraindication to degarelix or surgery
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
proliferative index defined by immunohistochemistry for ki67
Outcome Time Frame:
at surgery, 7-14 days after administration of degarelix
Safety Issue:
No
Principal Investigator
David Neal, BSc MS FRCS
Investigator Role:
Study Chair
Investigator Affiliation:
Cambridge University
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
11/H0311/2
NCT ID:
NCT01852864
Start Date:
July 2011
Completion Date:
December 2015
Related Keywords:
- Prostate Cancer
- Prostate cancer
- testosterone
- castration
- degarelix
- proliferation
- Prostatic Neoplasms
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