Androcur Non-interventional Study Among Patients With Carcinoma of the Prostate

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Cyproterone Acetate (Androcur, BAY94-8367)

• Registration Number: NCT00919022
• Lead Sponsor: Bayer

Brief Summary

Cyproterone acetate (CPA) is a steroidal antiandrogen which has affinity with progesterone and with glucocorticoid receptors. Cyproterone acetate is long-term proven effective treatment of inoperable carcinoma of the prostate.

Sexual functions remain very important in men with prostate cancer. However sexual functions are deteriorating fast with course of the disease. The influence of CPA on sexual functions remains controversial. IIEF-5 erectile dysfunction questionnaire is currently widely used validated simple scoring system for diagnosing of erectile dysfunction and belongs to most used systems in Czech Republic. At present there are no data on CPA influence on IIEF-5 scored erectile dysfunction within the use of its indication in prostate cancer.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Study Start: 2009-08
• Study Completion: 2011-08
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-30
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 194

Inclusion Criteria

• Males > 18 years previously untreated with Androcur.
• No contraindication to Androcur.

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Exclusion Criteria

• Liver diseases, malignant liver tumours and wasting diseases (except for carcinoma of the prostate). A history of or existing thrombosis or embolism. Severe chronic depression. Hypersensitivity to cyproterone. Cyproterone acetate in previous therapy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Cyproterone Acetate (Androcur, BAY94-8367)	-

Primary Outcome Measures

Name	Time	Method
Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire)	6 months

Secondary Outcome Measures

Name	Time	Method
Correlation of PSA level and erectile dysfunction	6 months
Sexual activity of Czech patients with inoperable prostate cancer	6 months