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

NCT00919022 | Terminated

• 2 other identifiers: 14556AC0910CZ
• Study Type: observational
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Inoperable Prostate Cancer; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (2)

• Correlation of PSA level and erectile dysfunction

  6 months

• Sexual activity of Czech patients with inoperable prostate cancer

  6 months

Study Arms (1)

Group 1

Drug: Cyproterone Acetate (Androcur, BAY94-8367)

Interventions

Cyproterone Acetate (Androcur, BAY94-8367) DRUG

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Random sample of cancer patients visiting oncologist or urologist ambulance who are suitable for standard Cyproterone treatment.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Czechia

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Erectile Dysfunction

Interventions

Cyproterone Acetate

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyproterone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: August 1, 2009
• Study Completion: August 1, 2011
• Last Updated: November 1, 2012

Record last verified: 2012-10

Locations

CZ (1)