Degarelix Before Radical Prostatectomy
Early Phase 1
- Conditions
- Prostate Cancer
- Interventions
- Drug: 240mg degarelix s.c. injection
- Registration Number
- NCT01852864
- Lead Sponsor
- University of Cambridge
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 40
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Degarelix treated group 240mg degarelix s.c. injection 240mg degarelix s.c. injection to be administered 7 days prior to radical prostatectomy for high/intermediate risk prostate cancer.
- Primary Outcome Measures
Name Time Method proliferative index defined by immunohistochemistry for ki67 at surgery, 7 days after administration of degarelix
- Secondary Outcome Measures
Name Time Method Gene expression levels measured by microarray At surgery 7 days after degarelix administration
Trial Locations
- Locations (1)
Cambridge University Hopital NHS Trust
🇬🇧Cambridge, Cambridgeshire, United Kingdom