Study Completed

Prostate Cancer

Bayer Identifier:

14166

ClinicalTrials.gov Identifier:

NCT00908674

EudraCT Number:

Not Available

EU CT Number:

Not Available

Androcur Effects on Quality of Life

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

18 Years

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
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

Trial summary

Enrollment Goal

245

Trial Dates

June 2008 - January 2010

Phase

N/A

Could I Receive a placebo

Products

Androcur (Cyproterone Acetate, BAY94-8367)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Hungary

Primary Outcome

Quality of life change measured by SF-35 questionnaire
Time Frame:
Baseline, after 3, 6 and 12 month
Safety Issue:
No

Trial design

Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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