Study of Treatment Choice in Patients With Localized Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer

• Registration Number: NCT01177865
• Lead Sponsor: University College London Hospitals

Brief Summary

RATIONALE: Gathering information about patients with prostate cancer may help doctors learn more about how patients choose treatment options.

PURPOSE: This study is looking at treatment choice in patients with localized prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* To evaluate the importance of prostate cancer treatment characteristics to men with localized prostate cancer.

* To determine to what extent men will choose the strengths and weaknesses of one treatment over a different set of strengths and weaknesses of another treatment when making a choice between them.

Secondary

* To determine the correlation between attributes that are important to men and baseline demographics, functional status, and disease risk characteristics.

OUTLINE: This is a multicenter study.

Patients complete a 'discrete choice experiment' questionnaire presenting three treatment options based on 8 aspects of treatment. Attributes relevant to men with prostate cancer (e.g., sexual health, urinary function, return to normal activities \[work, gardening, sports, shopping\]) that apply to surveillance, radical therapies and new minimally-invasive therapies have been selected for consideration. Baseline demographics such as age, working/retired/unemployed/household income, prostate cancer characteristics (PSA level, Gleason grade, stage), baseline functional status (genitourinary function), and final treatment choice will also be collected in order to ascertain whether there is any relationship and association between patient preferences for treatment and these baseline demographics. Individuals will be asked to choose between the three treatment profiles.

Study Timeline

• Study First Submitted: 2010-08-06
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Study Start: 2010-09
• Status Verified: 2010-11
• Primary Completion: 2012-09
• Last Update Submitted: 2013-08-23
• Last Update Posted: 2013-08-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 432

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
Treatment choice in respect to risks to sexual function and urinary function, return to normal activities, aim to treat the whole gland or only cancer areas or important cancer areas, retreatment rate, and mortality rate

Secondary Outcome Measures

Name	Time	Method
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics

Trial Locations

Locations (1)

University College of London Hospitals; 🇬🇧 London, England, United Kingdom