Prostate CancerNCT00908674
Androcur Effects on Quality of Life
An observational study of Prostate Cancer, run by Bayer at 1 site in Hungary.
Trial summary
Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is used for treatment of advanced prostate cancer. This study investigates the effect of Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months 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)
- How many people
- 245 participants
- Where
- 1 siteHungary
- Study dates
- Jun 2008to Jan 2010
- 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: Patients with advanced prostate cancer
Who may be able to join
- Histologically confirmed adenocarcinoma of the prostate
- Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
- Locally advanced tumor or distant metastases is present
Who cannot join
- Patient not fulfil the recruitment criteria
- Liver disease; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia.
- As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before the use of Androcur
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients
Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is used for treatment of advanced prostate cancer. This study investigates the effect of Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months
- Conditions
- Prostate Cancer
- Being tested
- Cyproterone acetate (Androcur)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproterone acetate (Androcur)Drug
The study drug will be administered either as monotherapy or in combination with other interventions (surgical castration or LHRH analogue treatment).
Daily dosage as monotherapy: 200-300 mg cyproterone acetate. Daily dosage following surgical castration: 100-200 mg cyproterone acetate. Daily dosage in combination with an LHRH-analogue: 100-200 mg cyproterone acetate.
Administration period: 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Cyproterone acetate (Androcur) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life change measured by SF-35 questionnaire
Measured: Baseline, after 3, 6 and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJun 2008
- Primary completionJan 2010
- Study completionJan 2010
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
- 245 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
- NCT00908674
- Sponsor's protocol ID
- 14166
- Other IDs
- AC0710HU
- Status last verified
- Apr 2010
- First submitted
- 24 Mar 2009
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT00908674
- Acronym / sponsor ID
- 14166
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 27 May 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.
Androcur is an antiandrogenic drug, which blocks the action of male sex hormones. Androcur is used for treatment of advanced prostate cancer. This study investigates the effect of Androcur on quality of life of prostate cancer patients who are taking the drug for 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Cyproterone acetate (Androcur) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced prostate cancer
Key inclusion criteria (3 listed)
- Histologically confirmed adenocarcinoma of the prostate
- Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
- Locally advanced tumor or distant metastases is present
Key exclusion criteria (3 listed)
- Patient not fulfil the recruitment criteria
- Liver disease; Dubin-Johnson syndrome; Rotor syndrome; previous or existing liver tumours (in carcinoma of the prostate only if these are not due to metastases); wasting diseases (with the exception of carcinoma of the prostate); depression; previous or existing thromboembolic processes; diabetes with vascular changes; sickle-cell anaemia.
- As regards patients with prostatic carcinoma who have a history of thromboembolic processes and/or an existing sickle-cell anaemia, or diabetes with vascular changes, the risk:benefit ratio must be considered carefully in each individual case before the use of Androcur
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)The study drug will be administered either as monotherapy or in combination with other interventions (surgical castration or LHRH analogue treatment). Daily dosage as monotherapy: 200-300 mg cyproterone acetate. Daily dosage following surgical castration: 100-200 mg cyproterone acetate. Daily dosage in combination with an LHRH-analogue: 100-200 mg cyproterone acetate. Administration period: 12 months. | Drug | Group 1 |
Primary outcome
Quality of life change measured by SF-35 questionnaire
Time frame: Baseline, after 3, 6 and 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
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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 Hungary.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 13 Apr 2010. 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 Hungary. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life change measured by SF-35 questionnaire (time frame: Baseline, after 3, 6 and 12 month). 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 13 Apr 2010.