NCT01545882

A Phase II Study of Degarelix in the Management of Non-Metastatic Hormone-Refractory Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being offered to patients who have hormone resistant prostate cancer (HRPC). This means that their prostate cancer is no longer responding to standard hormonal therapy. The purpose of this study is to determine whether Degarelix will be able to stop the PSA from rising in patients with hormone resistant prostate cancer.

Detailed description

This is a phase II study of a GnRH antagonist drug, Degarelix, for use in hormone resistant prostate cancer patients who have had biochemical PSA progression despite the use of total androgen blockade therapy. Patients will receive at least six monthly injections of Degarelix unless the patient shows radiographic or symptomatic disease progression, intolerable toxicity or decides to withdraw from the study. Patients will be evaluated for measures of efficacy, toxicity and disease progression during treatment and afterwards until radiologically confirmed metastatic disease progression or until the patient is removed from the study. Overall objective: The efficacy of Degarelix as a treatment for HRPC will be evaluated

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Degarelix	Treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2013-07-01
• First posted: 2012-03-07
• Last updated: 2020-05-07

Locations

3 sites across 1 country: Canada