Androcur Effects on Quality of Life

Bayer

Status: Completed

Conditions: Prostate Cancer

Treatments: Drug: Cyproterone acetate (Androcur)

Study type: Observational

Funder types: Industry

Identifiers

NCT00908674

AC0710HU

14166

Details and patient eligibility

About

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

Enrollment: 245 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

245 participants in 1 patient group

Group 1

Treatment:

Drug: Cyproterone acetate (Androcur)