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OpenTrials
Completed

NCT Number: NCT00908674

Androcur Effects on Quality of Life

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Many Locations, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quality of life change measured by SF-35 questionnaire

    Time frame: Baseline, after 3, 6 and 12 month

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 27, 2009
Registry last updated
Apr 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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