Androcur Effects on Quality of Life

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908674
• Other study ID #: 14166
• Secondary ID: AC0710HU
• Status: Completed
• Phase: N/A
• First received: March 24, 2009
• Last updated: April 12, 2010
• Start date: June 2008
• Est. completion date: January 2010

Study information

• Verified date: April 2010
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Council of Health Sciences Egeszsegügyi Tudomanyos Tanacs
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life change measured by SF-35 questionnaire		Baseline, after 3, 6 and 12 month	No

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