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

An Extension Long-Term Safety and Tolerability Trial of Degarelix, Following a 1-year Open-Label, Multi-Centre, Randomised, Parallel-group Trial in Which the Efficacy and Safety of Degarelix One-month Dosing Regimen Was Compared With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02015871

Acronym

PandaExtension

Enrollment

206

Registered

2013-12-19

Start date

2014-01-31

Completion date

2017-08-01

Last updated

2023-06-18

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

Conditions

Prostate Cancer

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.

Interventions

DRUGDegarelix

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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* Has been withdrawn/discontinued from the 000006 trial.

Design outcomes

Primary

Measure	Time frame
Number and percentage of patients with Adverse Events (AEs)	Baseline to Month 26
Change in ECG parameters	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

Measure	Time frame	Description
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)
Change in testosterone levels	Baseline to Month 26	—

Countries

China

Outcome results

None listed

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