Degarelix Before Radical Prostatectomy | NCT01852864

Studies
Degarelix Before Radical Prostatectomy

NCT01852864

Sponsor

University of Cambridge

Status

Unknown status

Last Update Posted

Dec 16, 2014Estimated

Enrollment

40Estimated

Phase

Early Phase 1

Conditions

Prostate Cancer

Interventions

240mg degarelix s.c. injection

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jul 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

May 6, 2013

First Submission Date that Met QC Criteria

May 9, 2013

First Posted Date

May 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 15, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Greg Shaw, Clinical Lecturer in Urology, University of CambridgePrincipal Investigator

Lead Sponsor

University of CambridgeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Degarelix treated group	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
240mg degarelix s.c. injection	Drug	7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.	Degarelix treated group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proliferative index defined by immunohistochemistry for ki67		at surgery, 7 days after administration of degarelix

Secondary Outcomes

Measure	Description	Time Frame
Gene expression levels measured by microarray		At surgery 7 days after degarelix administration

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Greg Shaw, MBBS MD FRCS	Contact	01223 331940		greg.shaw@cruk.cam.ac.uk
Marie Corcoran	Contact	01223348441		marie.corcoran@addenbrookes.nhs.uk

Overall Officials

Name	Affiliation	Role
David Neal, BSc MS FRCS	Cambridge University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cambridge University Hopital NHS Trust	Recruiting	Cambridge	Cambridgeshire	CB20QQ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided