An Extension Long-term Safety and Tolerability Trial of Degarelix in Chinese Patients With Prostate Cancer

Phase 3

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: Degarelix

• Registration Number: NCT02015871
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

This trial is an open-label, multi-centre, single arm extension for the 000006 trial in Chinese patients with prostate cancer. Eligible patients will receive monthly (28-day intervals) maintenance doses of 80 mg (20 mg/mL) degarelix administered by subcutaneous (s.c.) injection for a period of 2 years from first visit in this extension trial. Patients, who received goserelin treatment in the main trial, will get a degarelix starting dose (240 mg; 40 mg/mL) at the first visit and continue on degarelix treatment. The purpose of this 2-year extension trial is to collect long-term safety and tolerability data for the one-month dosing regimen.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-13
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-19
• Study Start: 2014-01
• Status Verified: 2017-08
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 206

Inclusion Criteria

• Has given written informed consent before any trial-related activity is performed. A trial-related activity is defined as any procedure that would not have been performed during the normal management of the patient
• Has completed the 000006 trial

Exclusion Criteria

• Has been withdrawn/discontinued from the 000006 trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Degarelix	Degarelix	-

Primary Outcome Measures

Name	Time	Method
Change in ECG parameters	Baseline to Month 26
Number and percentage of patients with Adverse Events (AEs)	Baseline to Month 26
Change in body weight and vital signs	Baseline to Month 26
Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)	Baseline to Month 26

Secondary Outcome Measures

Name	Time	Method
Change in testosterone levels	Baseline to Month 26
Change in prostate-specific antigen (PSA) levels	Baseline to Month 26
Cumulative probability of no PSA failure	Baseline to Month 26	PSA failure is defined as two consecutive (at least two weeks apart) increases of 50%, and at least 5 ng/mL, compared to nadir (obtained in either trial 000006 or trial 000006A)

Trial Locations

Locations (1)

Peking University People's Hospital (there may be multiple sites in this country); 🇨🇳 Beijing, Beijing, China