Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
245 participants
OBSERVATIONAL
2008-06-30
2010-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
Cyproterone acetate (Androcur)
The study drug will be administered either as monotherapy or in combination with other interventions (surgical castration or LHRH analogue treatment).
Daily dosage as monotherapy: 200-300 mg cyproterone acetate. Daily dosage following surgical castration: 100-200 mg cyproterone acetate. Daily dosage in combination with an LHRH-analogue: 100-200 mg cyproterone acetate.
Administration period: 12 months.
Interventions
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Cyproterone acetate (Androcur)
The study drug will be administered either as monotherapy or in combination with other interventions (surgical castration or LHRH analogue treatment).
Daily dosage as monotherapy: 200-300 mg cyproterone acetate. Daily dosage following surgical castration: 100-200 mg cyproterone acetate. Daily dosage in combination with an LHRH-analogue: 100-200 mg cyproterone acetate.
Administration period: 12 months.
Eligibility Criteria
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Inclusion Criteria
* Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
* Locally advanced tumor or distant metastases is present
Exclusion Criteria
* Liver disease; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia.
* As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before the use of Androcur
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer Hungária Kft.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Many Locations, , Hungary
Countries
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Other Identifiers
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AC0710HU
Identifier Type: -
Identifier Source: secondary_id
14166
Identifier Type: -
Identifier Source: org_study_id
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