Skip to content

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

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)

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00919022
Acronym
ANES
Enrollment
194
Registered
2009-06-11
Start date
2009-08-31
Completion date
2011-08-31
Last updated
2012-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Inoperable Prostate Cancer, Erectile Dysfunction

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.

Interventions

Patients in regular clinical practice receiving Androcur according to local drug information

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
Correlation of PSA level and erectile dysfunction6 months
Sexual activity of Czech patients with inoperable prostate cancer6 months

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026