Trial Condition(s):
Prostate Cancer
Androcur Non-interventional study among patients with carcinoma of the prostate (ANES)
Bayer Identifier:
14556
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Males > 18 years previously untreated with Androcur. - No contraindication to Androcur.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Czech Republic | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Prospective observational non-interventional study of correlation of treatment with Androcur, disease stage, testosterone level, age with sexual function and erectile dysfunction (measured by IIEF-5 validated questionnaire)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire)Timeframe: 6 months
Secondary Outcome
- Correlation of PSA level and erectile dysfunctionTimeframe: 6 months
- Sexual activity of Czech patients with inoperable prostate cancerTimeframe: 6 months
Additional Information
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