Androcur Effects on Quality of Life
- Registration Number
- NCT00908674
- Lead Sponsor
- Bayer
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 245
Inclusion Criteria
- Histologically confirmed adenocarcinoma of the prostate
- Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
- Locally advanced tumor or distant metastases is present
Read More
Exclusion Criteria
- 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
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Cyproterone acetate (Androcur) -
- Primary Outcome Measures
Name Time Method Quality of life change measured by SF-35 questionnaire Baseline, after 3, 6 and 12 month
- Secondary Outcome Measures
Name Time Method