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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01744366
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Degarelix Drug: Goserelin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2013
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Degarelix
Degarelix 240/80 mg
Drug: Degarelix
Active Comparator: Goserelin
Goserelin 3.6 mg
Drug: Goserelin



Primary Outcome Measures :
  1. Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) [ Time Frame: Day 28 to Day 364 ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01744366


Locations
Show Show 29 study locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
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Study Director: Clinical Development Support Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01744366    
Other Study ID Numbers: 000006
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents