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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00116753 |
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Date of registration:
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30/06/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Comparative Study of Degarelix Three-month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer
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Scientific title:
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An Open-label Multi-center, Randomized Parallel Group Comparison of Efficacy and Safety of Degarelix Three-Month Depot in Three Different Dosing Regimens in Patients With Prostate Cancer |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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460 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00116753 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Canada
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Finland
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Former Serbia and Montenegro
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France
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Germany
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Netherlands
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Romania
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Russian Federation
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Development Support |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ferring Pharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Has given written consent before any study-related activity is performed. A
study-related activity is defined as any procedure that would not have been performed
during the normal management of the patient.
- Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all
stages) in whom endocrine treatment, except for neoadjuvant hormonal therapy, is
indicated. This includes patients with rising PSA after having undergone prostatectomy
or radiotherapy with curative intention.
- Is a male patient aged 18 years or over.
- Has a baseline serum testosterone level above the lower limit of normal range,
globally defined as >2.2 ng/mL.
- Has an ECOG (Eastern Cooperative Oncology Group) score of 2.
- Has a PSA value of 2 ng/mL.
- Has a life expectancy of at least 13 months.
Exclusion Criteria:
- Has had previous or is currently under hormonal management of prostate cancer
(surgical castration or other hormonal manipulation, e.g. GnRH agonists, GnRH
antagonists, antiandrogens, oestrogens). However, patients having undergone
prostatectomy or radiotherapy with curative intention, neoadjuvant hormonal therapy is
accepted for a maximal duration of 6 months. This treatment should have been
terminated at least 6 months prior to the Screening Visit.
- Is considered to be a candidate for curative therapy, i.e. radical prostatectomy or
radiotherapy within 13 months from Screening Visit.
- Has a history of, or predisposition to, severe hypersensitivity reactions such as
severe asthma (defined as a need for daily treatment with inhalation steroids to
control the asthma), anaphylactic reactions, or chronic or recurrent urticaria and/or
angioedema.
- Has hypersensitivity towards any component of the investigational medicinal product.
5. Has had a cancer disease within the last five years except for prostate cancer and
surgically removed basal or squamous cell carcinoma of the skin.
- Has a known or suspected hepatic or symptomatic biliary disease.
- Has elevated serum ALT level above upper level of normal range or serum total
bilirubin level above upper level of normal range as measured by the laboratory at the
Screening Visit.
- Has other clinically significant laboratory abnormalities, which in the judgment of
the investigator would interfere with the patient's participation in this study or
evaluation of study results.
- Has a clinically significant disorder (other than prostate cancer) or any other
condition, including excessive alcohol or drug abuse, which may interfere with study
participation or which may affect the conclusion of the study as judged by the
investigator.
- Has a mental incapacity or language barriers precluding adequate understanding or
cooperation.
- Has received an investigational drug within the last 28 days preceding Screening Visit
or longer if considered by the investigator to possibly influence the outcome of the
current study.
- Has previously participated in any degarelix study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Drug: Degarelix
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Primary Outcome(s)
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Number of Participants With Testosterone Level <=0.5 ng/mL From Day 28 Until the End of the Study
[Time Frame: From Day 28 to 12 or 13 months]
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Secondary Outcome(s)
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Liver Function Tests
[Time Frame: 12 or 13 months]
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Number of Participants With Markedly Abnormal Change in Vital Signs and Body Weight as Compared to Baseline
[Time Frame: 12 or 13 months]
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Number of Participants With Testosterone Level <=0.5 ng/mL After the Dose at Day 28 Until the End of the Study
[Time Frame: From after Day 28 to 12 or 13 months]
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Number of Participants With Testosterone <=0.5 ng/mL at Day 28
[Time Frame: 28 Days]
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Secondary ID(s)
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FE200486 CS15
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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