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

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ClinicalTrials.gov Identifier: NCT00919022
Recruitment Status : Terminated
First Posted : June 11, 2009
Last Update Posted : November 1, 2012
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment
Prostate Cancer Drug: Cyproterone Acetate (Androcur, BAY94-8367)

Study Type : Observational
Actual Enrollment : 194 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Study Start Date : August 2009
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Cyproterone Acetate (Androcur, BAY94-8367)
Patients in regular clinical practice receiving Androcur according to local drug information



Primary Outcome Measures :
  1. Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Correlation of PSA level and erectile dysfunction [ Time Frame: 6 months ]
  2. Sexual activity of Czech patients with inoperable prostate cancer [ Time Frame: 6 months ]

Biospecimen Retention:   None Retained
n.a.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Random sample of cancer patients visiting oncologist or urologist ambulance who are suitable for standard Cyproterone treatment.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919022


Locations
Czech Republic
Many Locations, Czech Republic
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Medical Director, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00919022     History of Changes
Other Study ID Numbers: 14556
AC0910CZ ( Other Identifier: Company internal )
First Posted: June 11, 2009    Key Record Dates
Last Update Posted: November 1, 2012
Last Verified: October 2012

Keywords provided by Bayer:
Inoperable Prostate Cancer
Erectile Dysfunction

Additional relevant MeSH terms:
Prostatic Neoplasms
Erectile Dysfunction
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders
Cyproterone
Cyproterone Acetate
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents