Prostate CancerPhase 3PANDANCT01744366
One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population
A Phase 3 study testing Degarelix and Goserelin in people with Prostate Cancer, run by Ferring Pharmaceuticals at 29 sites in China.
Trial summary
One month degarelix/comparator treatment for prostate cancer in Chinese population Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Degarelix and Goserelin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 29 sitesChina
- Study dates
- Jan 2013to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
China29 sites
Cancer Institute & Hospital. Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Beijing Hospital of Ministry of Health
Beijing
Peking Union Hospital
Beijing
Peking University 3rd Hospital
Beijing
Peking University People's Hospital
Beijing
1st Hospital of Jilin University
Changchun
Hunan Cancer Hospital
Changsha
Hunan Province People's Hospital
Changsha
People's Hospital of Sichuan
Chengdu
Affiliated Southwest Hospital of 3rd Military Medical University of People's Liberation Army
Chongqing, Chongqing Municipality
1st Afilliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong
1st Hospital Affiliated to Zhejiang University Medical School
Hangzhou, Zhejiang
2nd Hospital Affiliated to Zhejiang University Medical School
Hangzhou
1st Hospital of Lanzhou University
Lanzhou
1st Affiliated Hospital of Nanchang University
Nanchang
1st Affiliated Hospital of Nanjing Medical University
Nanjing
Drum Tower Hospital Affiliated to Nanjing University Medical School
Nanjing
Fudan University Shanghai Cancer Center
Shanghai
Huashan Hospital of Fudan University
Shanghai
Shanghai 5th People's Hospital affilicated to Fudan University
Shanghai
Shanghai Changhai Hospital
Shanghai
1st Hospital Affiliated to China Medical University
Shenyang
2nd Hospital Affiliated to Suzhou University
Suzhou
2nd Hospital of Tianjin Medical University
Tianjin
Renmin Hospital of Wuhan University
Wuhan, Hubei
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Zhongnan Hospital of Wuhan University
Wuhan
1st People's Hospital of Wuxi
Wuxi
2nd.Affiliated Hospital of Xi'an Jiaotong University College of Medicine
Xi’an, Shanxi
About this study
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
One month degarelix/comparator treatment for prostate cancer in Chinese population
- Conditions
- Prostate Cancer
- Being tested
- Degarelix, Goserelin
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
GoserelinDrug
| Study group | Role | What they receive |
|---|---|---|
| Degarelix | Experimental | Degarelix 240/80 mg Receives: Drug: Degarelix |
| Goserelin | Active comparator | Goserelin 3.6 mg Receives: Drug: Goserelin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Measured: Day 28 to Day 364
Secondary outcomes (8)
Proportion of patients with testosterone levels ≤0.5 ng/mL
Measured: at Day 3
Percentage change in prostate-specific antigen (PSA)
Measured: from baseline to Day 28
Changes in testosterone and PSA levels
Measured: Day 0 to 364
Significant changes in laboratory values
Measured: Day 0 to Day 364
Significant changes in vital signs
Measured: Day 0 to Day 364
Significant changes in body weight
Measured: Day 0 to Day 364
Frequency and severity of adverse events
Measured: Day 0 to Day 364
Cumulative probability of no PSA failure
PSA failure defined as two consecutive (at least two weeks apart) increase of 50 percentage and at least 5ng/mL increase compared to nadir
Measured: Day 0 to Day 364
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01744366
- Sponsor's protocol ID
- 000006
- Acronym
- PANDA
- Status last verified
- Jun 2015
- First submitted
- 5 Dec 2012
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
PubMed 34350976
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01744366
- Acronym / sponsor ID
- PANDA / 000006
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One month degarelix/comparator treatment for prostate cancer in Chinese population
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degarelix | Experimental | Drug: DegarelixDegarelix 240/80 mg |
| Goserelin | Active comparator | Drug: GoserelinGoserelin 3.6 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Degarelix | Drug | Degarelix |
| Goserelin | Drug | Goserelin |
Primary outcome
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Time frame: Day 28 to Day 364
8 secondary outcomes
Proportion of patients with testosterone levels ≤0.5 ng/mL
Time frame: at Day 3
Percentage change in prostate-specific antigen (PSA)
Time frame: from baseline to Day 28
Changes in testosterone and PSA levels
Time frame: Day 0 to 364
Significant changes in laboratory values
Time frame: Day 0 to Day 364
Significant changes in vital signs
Time frame: Day 0 to Day 364
Significant changes in body weight
Time frame: Day 0 to Day 364
Frequency and severity of adverse events
Time frame: Day 0 to Day 364
Cumulative probability of no PSA failure
Time frame: Day 0 to Day 364
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Derived from this study: PubMed 34350976Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Degarelix and Goserelin in people with Prostate Cancer, run by Ferring Pharmaceuticals at 29 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL) (time frame: Day 28 to Day 364). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01744366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2015.