Androcur Effects on Quality of Life - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00908674

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

Condition	Intervention
Prostate Cancer	Drug: Cyproterone acetate (Androcur)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Cyproterone acetate Cyproterone

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Quality of life change measured by SF-35 questionnaire [ Time Frame: Baseline, after 3, 6 and 12 month ] [ Designated as safety issue: No ]

Enrollment:	245
Study Start Date:	June 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Groups/Cohorts

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with advanced prostate cancer

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908674

Locations

Hungary

Many Locations, Hungary

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Bayer Hungária Kft.
ClinicalTrials.gov Identifier:	NCT00908674 History of Changes
Other Study ID Numbers:	14166, AC0710HU
Study First Received:	March 24, 2009
Last Updated:	April 12, 2010
Health Authority:	Hungary: Council of Health Sciences Egeszsegügyi Tudomanyos Tanacs

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cyproterone Acetate
Cyproterone
Diane

Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012