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

This study has been terminated.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00919022
First received: June 9, 2009
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  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.


Condition Intervention
Prostate Cancer
 Drug: Cyproterone Acetate (Androcur, BAY94-8367)

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of PSA level and erectile dysfunction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Sexual activity of Czech patients with inoperable prostate cancer [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 194
Study Start Date: August 2009
Study Completion Date: August 2011
Groups/Cohorts Assigned Interventions
Group 1 Drug: Cyproterone Acetate (Androcur, BAY94-8367)
Patients in regular clinical practice receiving Androcur according to local drug information

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919022

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

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00919022     History of Changes
Other Study ID Numbers: 14556, AC0910CZ
Study First Received: June 9, 2009
Last Updated: October 30, 2012
Health Authority: Czech Republic: State Institute for Drug Control

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
Sexual and Gender Disorders
Mental Disorders
Cyproterone
 Cyproterone Acetate
Diane
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on June 13, 2013