Degarelix Before Radical Prostatectomy
|ClinicalTrials.gov Identifier: NCT01852864|
Recruitment Status : Unknown
Verified December 2014 by Greg Shaw, University of Cambridge.
Recruitment status was: Recruiting
First Posted : May 14, 2013
Last Update Posted : December 16, 2014
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|
|Prostate Cancer||Drug: 240mg degarelix s.c. injection||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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 :||July 2011|
|Estimated Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||December 2015|
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 Name: medical castration
- proliferative index defined by immunohistochemistry for ki67 [ Time Frame: at surgery, 7 days after administration of degarelix ]
- Gene expression levels measured by microarray [ Time Frame: At surgery 7 days after degarelix administration ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852864
|Contact: Greg Shaw, MBBS MD FRCS||01223 firstname.lastname@example.org|
|Contact: Marie Corcoranemail@example.com|
|Cambridge University Hopital NHS Trust||Recruiting|
|Cambridge, Cambridgeshire, United Kingdom, CB20QQ|
|Contact: Greg Shaw|
|Principal Investigator: David Neal, MS FRCS|
|Study Chair:||David Neal, BSc MS FRCS||Cambridge University|