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

June 22, 2015 updated by: Ferring Pharmaceuticals

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Degarelix
Degarelix 240/80 mg
Drug: Degarelix
Active Comparator: Goserelin
Goserelin 3.6 mg
Drug: Goserelin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cumulative probability of testosterone at castrate level (≤0.5 ng/mL)
Time Frame: Day 28 to Day 364
Day 28 to Day 364

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients with testosterone levels ≤0.5 ng/mL
Time Frame: at Day 3
at Day 3
Percentage change in prostate-specific antigen (PSA)
Time Frame: from baseline to Day 28
from baseline to Day 28
Changes in testosterone and PSA levels
Time Frame: Day 0 to 364
Day 0 to 364
Significant changes in laboratory values
Time Frame: Day 0 to Day 364
Day 0 to Day 364
Significant changes in vital signs
Time Frame: Day 0 to Day 364
Day 0 to Day 364
Significant changes in body weight
Time Frame: Day 0 to Day 364
Day 0 to Day 364
Frequency and severity of adverse events
Time Frame: Day 0 to Day 364
Day 0 to Day 364
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
Day 0 to Day 364

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ferring Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 000006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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