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Completed

NCT Number: NCT02015871

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital (there may be multiple sites in this country)

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Has been withdrawn/discontinued from the 000006 trial.

Treatment and study plan

degarelix

Drug

Primary outcomes

  1. Number and percentage of patients with Adverse Events (AEs)

    Time frame: Baseline to Month 26

  2. Change in ECG parameters

    Time frame: Baseline to Month 26

  3. Change in body weight and vital signs

    Time frame: Baseline to Month 26

  4. Clinically significant changes in laboratory values (clinical chemistry, haematology, and urinalysis)

    Time frame: Baseline to Month 26

Secondary outcomes

  1. Change in testosterone levels

    Time frame: Baseline to Month 26

  2. Change in prostate-specific antigen (PSA) levels

    Time frame: Baseline to Month 26

  3. Cumulative probability of no PSA failure

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: PandaExtension

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2013
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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