Skip to main content
OpenTrials
Completed

NCT Number: NCT01744366

One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population

One month degarelix/comparator treatment for prostate cancer in Chinese population

Completed

Looking for future studies?

Notify Me

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

Cancer Institute & Hospital. Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chinese male over 18 years
  • Adenocarcinoma of the prostate
  • Relevant disease status based on lab values and as judged by the physician
  • Life expectancy of at least a year

Exclusion criteria

  • Previous hormonal treatment for prostate cancer
  • Considered to be candidate for curative therapy
  • Risk or history of any serious or significant health condition
  • Has received an investigational drug within the last 28 days and no previous treatment with degarelix

Treatment and study plan

degarelix

Drug

Goserelin

Drug

Primary outcomes

  1. Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)

    Time frame: Day 28 to Day 364

Secondary outcomes

  1. Proportion of patients with testosterone levels ≤0.5 ng/mL

    Time frame: at Day 3

  2. Percentage change in prostate-specific antigen (PSA)

    Time frame: from baseline to Day 28

  3. Changes in testosterone and PSA levels

    Time frame: Day 0 to 364

  4. Significant changes in laboratory values

    Time frame: Day 0 to Day 364

  5. Significant changes in vital signs

    Time frame: Day 0 to Day 364

  6. Significant changes in body weight

    Time frame: Day 0 to Day 364

  7. Frequency and severity of adverse events

    Time frame: Day 0 to Day 364

  8. Cumulative probability of no PSA failure

    Time frame: Day 0 to Day 364

    PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

An Open-label, Multi-centre, Randomised, Parallel-group Trial, Comparing Efficacy and Safety of Degarelix One-month Dosing Regimen With Goserelin in Chinese Patients With Prostate Cancer Requiring Androgen Ablation Therapy

Acronym: PANDA

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2012
Registry last updated
Jun 23, 2015

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.