Androcur Effects on Quality of Life

April 12, 2010 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with advanced prostate cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Cyproterone acetate (Androcur)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life change measured by SF-35 questionnaire
Time Frame: Baseline, after 3, 6 and 12 month
Baseline, after 3, 6 and 12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 24, 2009

First Submitted That Met QC Criteria

May 26, 2009

First Posted (Estimate)

May 27, 2009

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14166
  • AC0710HU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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