Prostate CancerANESNCT00919022
Androcur Non-interventional Study Among Patients With Carcinoma of the Prostate
An observational study of Prostate Cancer, run by Bayer at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cyproterone Acetate (Androcur, BAY94-8367)
- How many people
- 194 participants
- Where
- 1 siteCzechia
- Study dates
- Aug 2009to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Random sample of cancer patients visiting oncologist or urologist ambulance who are suitable for standard Cyproterone treatment.
Who may be able to join
- Males > 18 years previously untreated with Androcur.
- No contraindication to Androcur.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- Cyproterone Acetate (Androcur, BAY94-8367)
- Keywords
- Inoperable Prostate Cancer, Erectile Dysfunction
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproterone Acetate (Androcur, BAY94-8367)Drug
Patients in regular clinical practice receiving Androcur according to local drug information
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Cyproterone Acetate (Androcur, BAY94-8367) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of treatment with Androcur (concomitant treatment), disease stage, testosterone level, age with erectile dysfunction (measured by IIEF-5 validated questionnaire)
Measured: 6 months
Secondary outcomes (2)
Correlation of PSA level and erectile dysfunction
Measured: 6 months
Sexual activity of Czech patients with inoperable prostate cancer
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startAug 2009
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919022
- Sponsor's protocol ID
- 14556
- Other IDs
- AC0910CZ
- Acronym
- ANES
- Status last verified
- Oct 2012
- First submitted
- 9 Jun 2009
- Last updated
- 1 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00919022
- Acronym / sponsor ID
- ANES / 14556
- Conditions
- Prostate Cancer
- Keywords
- Inoperable Prostate Cancer, Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 194 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Cyproterone Acetate (Androcur, BAY94-8367) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Random sample of cancer patients visiting oncologist or urologist ambulance who are suitable for standard Cyproterone treatment.
Key inclusion criteria (2 listed)
- Males > 18 years previously untreated with Androcur.
- No contraindication to Androcur.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyproterone Acetate (Androcur, BAY94-8367)Patients in regular clinical practice receiving Androcur according to local drug information | Drug | Group 1 |
Primary outcome
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
2 secondary outcomes
Correlation of PSA level and erectile dysfunction
Time frame: 6 months
Sexual activity of Czech patients with inoperable prostate cancer
Time frame: 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Bayer at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2012; AzTrials last refreshed its copy on 7 Nov 2026.