Degarelix Before Radical Prostatectomy

University of Cambridge

Status and phase: Unknown; Early Phase 1

Conditions: Prostate Cancer

Treatments: Drug: 240mg degarelix s.c. injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01852864

11/H0311/2

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Degarelix treated group

Experimental group

Description:

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

Treatment:

Drug: 240mg degarelix s.c. injection