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Degarelix Before Radical Prostatectomy

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01852864
Enrollment
40
Registered
2013-05-14
Start date
2011-07-31
Completion date
2015-12-31
Last updated
2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Prostate cancer, testosterone, castration, degarelix, proliferation

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.

Interventions

DRUG240mg degarelix s.c. injection

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

Sponsors

University of Cambridge
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
proliferative index defined by immunohistochemistry for ki67at surgery, 7 days after administration of degarelix

Secondary

MeasureTime frame
Gene expression levels measured by microarrayAt surgery 7 days after degarelix administration

Countries

United Kingdom

Contacts

Primary ContactGreg Shaw, MBBS MD FRCS
greg.shaw@cruk.cam.ac.uk01223 331940
Backup ContactMarie Corcoran
marie.corcoran@addenbrookes.nhs.uk01223348441

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026