One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population (PANDA)
This study is currently recruiting participants.
Verified May 2013 by Ferring Pharmaceuticals
Sponsor:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01744366
First received: December 5, 2012
Last updated: May 3, 2013
Last verified: May 2013
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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: | April 2015 |
| Estimated Primary Completion Date: | April 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 | Not yet 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 | Not yet recruiting |
| Hangzhou, Zhejiang, China | |
| China | |
| Peking University People's Hospital | Recruiting |
| Beijing, China | |
| Peking Union Hospital | Recruiting |
| Beijing, China | |
| Peking University 3rd Hospital | Recruiting |
| Beijing, China | |
| Beijing Hospital of Ministry of Health | Recruiting |
| Beijing, China | |
| 1st Hospital of Jilin University | Recruiting |
| Changchun, China | |
| Hunan Province People's Hospital | Not yet recruiting |
| Changsha, China | |
| Hunan Cancer Hospital | Recruiting |
| Changsha, China | |
| Hunan Province People's Hospital | 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 | |
| 1st Affiliated Hospital of Nanjing Medical University | Recruiting |
| Nanjing, China | |
| Drum Tower Hospital Affiliated to Nanjing University Medical School | Recruiting |
| Nanjing, China | |
| Huashan Hospital of Fudan University | Recruiting |
| Shanghai, China | |
| Fudan University Shanghai Cancer Center | Recruiting |
| Shanghai, China | |
| Shanghai 5th People's Hospital affilicated to Fudan University | Recruiting |
| Shanghai, China | |
| Shanghai Changhai Hospital | Not yet recruiting |
| Shanghai, China | |
| 1st Hospital Affiliated to China Medical University | 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: | May 3, 2013 |
| 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 May 21, 2013