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

This study is currently recruiting participants.
Verified April 2014 by Ferring Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01744366
First received: December 5, 2012
Last updated: April 7, 2014
Last verified: April 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 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744366

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
China, Beijing
Cancer Institute & Hospital. Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China
China, Chongqing
Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army Recruiting
Chongqing, Chongqing, China
China, Guangdong
1st Afilliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China
China, Hubei
Renmin Hospital of Wuhan University Not yet recruiting
Wuhan, Hubei, China
China, Shanxi
2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine Recruiting
Xi'an, Shanxi, China
China, Zhejiang
1st Hospital Affiliated to Zhejiang University Medical School Recruiting
Hangzhou, Zhejiang, China
China
Peking University 3rd Hospital Recruiting
Beijing, China
Peking Union Hospital Recruiting
Beijing, China
Beijing Hospital of Ministry of Health Recruiting
Beijing, China
Peking University People's Hospital Recruiting
Beijing, China
1st Hospital of Jilin University Recruiting
Changchun, China
Hunan Cancer Hospital Recruiting
Changsha, China
Hunan Province People's Hospital Not yet recruiting
Changsha, China
People's Hospital of Sichuan Recruiting
Chengdu, China
2nd Hospital Affiliated to Zhejiang University Medical School Recruiting
Hangzhou, China
1st Hospital of Lanzhou University Recruiting
Lanzhou, China
1st Affiliated Hospital of Nanchang University Recruiting
Nanchang, China
Drum Tower Hospital Affiliated to Nanjing University Medical School Recruiting
Nanjing, China
1st Affiliated Hospital of Nanjing Medical University Recruiting
Nanjing, China
Shanghai 5th People's Hospital affilicated to Fudan University Recruiting
Shanghai, China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Shanghai Changhai Hospital Recruiting
Shanghai, China
Huashan Hospital of Fudan University Recruiting
Shanghai, China
1st Hospital Affiliated to China Medical University Not yet recruiting
Shenyang, China
2nd Hospital Affiliated to Suzhou University Recruiting
Suzhou, China
2nd Hospital of Tianjin Medical University Recruiting
Tianjin, China
Zhongnan Hospital of Wuhan University Not yet recruiting
Wuhan, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, China
1st People's Hospital of Wuxi Recruiting
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: April 7, 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 April 21, 2014