Androcur Effects on Quality of Life

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00908674
• Collaborator: (none)
• Enrollment: 245
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 12.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Prostate Cancer	Drug: Cyproterone acetate (Androcur)

Study Design

• Study Type: Observational
• Actual Enrollment: 245 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Measure of Androcur Effects on Quality of Life at Prostate Cancer Patients
• Study Start Date: Jun 1, 2008
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm

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.

Outcome Measures

Primary Outcome Measures

1. Quality of life change measured by SF-35 questionnaire [Baseline, after 3, 6 and 12 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Hungary

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00908674
• Other Study ID Numbers: 14166; AC0710HU
• First Posted: May 27, 2009
• Last Update Posted: Apr 13, 2010
• Last Verified: Apr 1, 2010

• Additional relevant MeSH terms: Prostatic Neoplasms; Cyproterone Acetate; Cyproterone

Study Results

No Results Posted as of Apr 13, 2010