Androcur Effects on Quality of Life | NCT00908674

Studies
Androcur Effects on Quality of Life

NCT00908674

Sponsor

Bayer

Status

Completed

Last Update Posted

Apr 13, 2010Estimated

Enrollment

245Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Cyproterone acetate (Androcur)

Countries

Hungary

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AC0710HU

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jan 2010Actual

Completion Date

Jan 2010Actual

First Submitted Date

Mar 24, 2009

First Submission Date that Met QC Criteria

May 26, 2009

First Posted Date

May 27, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2010

Last Update Posted Date

Apr 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

245Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Cyproterone acetate (Androcur)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with advanced prostate cancer

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017373	Cyproterone Acetate

Ancestor Terms

ID	Term
D003534	Cyproterone
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided