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

Prostate Cancer Clinical Trial

— ANES  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00919022
• Other study ID #: 14556
• Secondary ID: AC0910CZ
• Status: Terminated
• Phase: N/A
• First received: June 9, 2009
• Last updated: October 30, 2012
• Start date: August 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2012
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 194
• Est. completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Cyproterone Acetate (Androcur, BAY94-8367)
Patients in regular clinical practice receiving Androcur according to local drug information

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire)		6 months	No
Secondary	Correlation of PSA level and erectile dysfunction		6 months	No
Secondary	Sexual activity of Czech patients with inoperable prostate cancer		6 months	No

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