Degarelix Before Radical Prostatectomy

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01852864
• Other study ID #: 11/H0311/2
• Status: Recruiting
• Phase: Phase 0
• First received: May 6, 2013
• Last updated: December 15, 2014
• Start date: July 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University of Cambridge
• Contact: Greg Shaw, MBBS MD FRCS
• Phone: 01223 331940
• Email: greg.shaw[@]cruk.cam.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited kingdom: MHRA This study is not a CTIMP. MHRA have reviewed protocol and excluded need for further involvement
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• 240mg degarelix s.c. injection
7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hopital NHS Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proliferative index defined by immunohistochemistry for ki67		at surgery, 7 days after administration of degarelix	No
Secondary	Gene expression levels measured by microarray		At surgery 7 days after degarelix administration	No