NCT00203918

Brief Summary

The purpose of this study is to help doctors and patients make better decisions about prostate cancer treatment. This research is being done because we do not know how patient preferences for health states related to prostate cancer affect the final treatment decision.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
481

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 30, 2017

Status Verified

August 1, 2017

Enrollment Period

7.1 years

First QC Date

September 12, 2005

Last Update Submit

August 28, 2017

Conditions

Keywords

Prostate CancerCost-Effectiveness AnalysisUtility Assessment

Outcome Measures

Primary Outcomes (1)

  • Utility scores for treatment outcomes

    Patient utility scores (i.e. patient preference weights) are calculated using survery data will determine which prostate cancer treatment would be most cost-effective for each subject. Patients will be contacted by phone and patient records will be reviewed 90 days after the survey has been completed to determine whether this data reflects actual treatment decisions.

    90 days after enrollment

Secondary Outcomes (1)

  • Anxiety levels

    90 days after enrollment

Study Arms (1)

Prostate biopsies

Males undergoing prostate biopsies

Behavioral: Survey, interviewBehavioral: patient utility scores (i.e. patient preference weights)

Interventions

A survey is administered to patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand patients' individual evaluations of treatment-related health states. Medical records will also be reviewed 00 days after the survey was administered to determine whether this data reflects actual treatment decisions.

Prostate biopsies

comparison of patient preferences

Prostate biopsies

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients visiting the urology clinic at the University of Chicago.

You may qualify if:

  • Patients undergoing prostate biopsy

You may not qualify if:

  • Women and children will be excluded, as prostate cancer occurs in men only
  • Diagnosis of dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David Meltzer, M.D., Ph.D.

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Primary Completion

February 1, 2011

Study Completion

February 1, 2013

Last Updated

August 30, 2017

Record last verified: 2017-08

Locations