Androcur Effects on Quality of Life
Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients
2 other identifiers
observational
245
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 24, 2009
CompletedFirst Posted
Study publicly available on registry
May 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedApril 13, 2010
April 1, 2010
1.6 years
March 24, 2009
April 12, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of life change measured by SF-35 questionnaire
Baseline, after 3, 6 and 12 month
Study Arms (1)
Group 1
Interventions
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.
Eligibility Criteria
Patients with advanced prostate cancer
You may qualify if:
- Histologically confirmed adenocarcinoma of the prostate
- Inoperable prostate tumor or progradiated after surgery/ irradiation therapy
- Locally advanced tumor or distant metastases is present
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Unknown Facility
Many Locations, Hungary
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 24, 2009
First Posted
May 27, 2009
Study Start
June 1, 2008
Primary Completion
January 1, 2010
Study Completion
January 1, 2010
Last Updated
April 13, 2010
Record last verified: 2010-04