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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01744366
First received: December 5, 2012
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: Degarelix
Drug: Goserelin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) [ Time Frame: Day 28 to Day 364 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with testosterone levels ≤0.5 ng/mL [ Time Frame: at Day 3 ] [ Designated as safety issue: No ]
  • Percentage change in prostate-specific antigen (PSA) [ Time Frame: from baseline to Day 28 ] [ Designated as safety issue: No ]
  • Changes in testosterone and PSA levels [ Time Frame: Day 0 to 364 ] [ Designated as safety issue: No ]
  • Significant changes in laboratory values [ Time Frame: Day 0 to Day 364 ] [ Designated as safety issue: Yes ]
  • Significant changes in vital signs [ Time Frame: Day 0 to Day 364 ] [ Designated as safety issue: Yes ]
  • Significant changes in body weight [ Time Frame: Day 0 to Day 364 ] [ Designated as safety issue: Yes ]
  • Frequency and severity of adverse events [ Time Frame: Day 0 to Day 364 ] [ Designated as safety issue: Yes ]
  • Cumulative probability of no PSA failure [ Time Frame: Day 0 to Day 364 ] [ Designated as safety issue: No ]
    PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir


Estimated Enrollment: 280
Study Start Date: January 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Degarelix
Degarelix 240/80 mg
Drug: Degarelix
Active Comparator: Goserelin
Goserelin 3.6 mg
Drug: Goserelin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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:

  • No previous hormonal treatment for prostate cancer
  • Considered to be candidate for curative therapy
  • No 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744366

Locations
China, Beijing
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, Beijing, China
China, Chongqing
Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
Chongqing, Chongqing, China
China, Guangdong
1st Afilliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
China, Hubei
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
China, Shanxi
2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
Xi'an, Shanxi, China
China, Zhejiang
1st Hospital Affiliated to Zhejiang University Medical School
Hangzhou, Zhejiang, China
China
Peking University 3rd Hospital
Beijing, China
Peking Union Hospital
Beijing, China
Beijing Hospital of Ministry of Health
Beijing, China
Peking University People's Hospital
Beijing, China
1st Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
Hunan Province People's Hospital
Changsha, China
People's Hospital of Sichuan
Chengdu, China
2nd Hospital Affiliated to Zhejiang University Medical School
Hangzhou, China
1st Hospital of Lanzhou University
Lanzhou, China
1st Affiliated Hospital of Nanchang University
Nanchang, China
Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing, China
1st Affiliated Hospital of Nanjing Medical University
Nanjing, China
Shanghai 5th People's Hospital affilicated to Fudan University
Shanghai, China
Fudan University Shanghai Cancer Center
Shanghai, China
Shanghai Changhai Hospital
Shanghai, China
Huashan Hospital of Fudan University
Shanghai, China
1st Hospital Affiliated to China Medical University
Shenyang, China
2nd Hospital Affiliated to Suzhou University
Suzhou, China
2nd Hospital of Tianjin Medical University
Tianjin, China
Zhongnan Hospital of Wuhan University
Wuhan, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1st People's Hospital of Wuxi
Wuxi, China
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01744366     History of Changes
Other Study ID Numbers: 000006
Study First Received: December 5, 2012
Last Updated: May 26, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014