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Degarelix Before Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Greg Shaw, 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.


Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 240mg degarelix s.c. injection Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Degarelix

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. proliferative index defined by immunohistochemistry for ki67 [ Time Frame: at surgery, 7 days after administration of degarelix ]

Secondary Outcome Measures :
  1. Gene expression levels measured by microarray [ Time Frame: At surgery 7 days after degarelix administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852864


Contacts
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Contact: Greg Shaw, MBBS MD FRCS 01223 331940 greg.shaw@cruk.cam.ac.uk
Contact: Marie Corcoran 01223348441 marie.corcoran@addenbrookes.nhs.uk

Locations
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United Kingdom
Cambridge University Hopital NHS Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB20QQ
Contact: Greg Shaw         
Principal Investigator: David Neal, MS FRCS         
Sponsors and Collaborators
University of Cambridge
Investigators
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Study Chair: David Neal, BSc MS FRCS Cambridge University
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Responsible Party: Greg Shaw, Clinical Lecturer in Urology, University of Cambridge
ClinicalTrials.gov Identifier: NCT01852864    
Other Study ID Numbers: 11/H0311/2
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014
Keywords provided by Greg Shaw, University of Cambridge:
Prostate cancer
testosterone
castration
degarelix
proliferation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases