Degarelix Before Radical Prostatectomy

NCT ID: NCT01852864

Last Updated: 2014-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Prostate Cancer

Keywords

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Prostate cancer testosterone castration degarelix proliferation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Degarelix treated group

240mg degarelix s.c. injection to be administered 7 days prior to radical prostatectomy for high/intermediate risk prostate cancer.

Group Type EXPERIMENTAL

240mg degarelix s.c. injection

Intervention Type DRUG

7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.

Interventions

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240mg degarelix s.c. injection

7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.

Intervention Type DRUG

Other Intervention Names

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medical castration

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Cambridge

OTHER

Sponsor Role lead

Responsible Party

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Greg Shaw

Clinical Lecturer in Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Neal, BSc MS FRCS

Role: STUDY_CHAIR

Cambridge University

Locations

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Cambridge University Hopital NHS Trust

Cambridge, Cambridgeshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Greg Shaw, MBBS MD FRCS

Role: CONTACT

Phone: 01223 331940

Email: [email protected]

Marie Corcoran

Role: CONTACT

Phone: 01223348441

Email: [email protected]

Facility Contacts

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Greg Shaw

Role: primary

Other Identifiers

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11/H0311/2

Identifier Type: -

Identifier Source: org_study_id