Study of Treatment Choice in Patients With Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01177865
• Other study ID #: CDR0000682206
• Secondary ID: UCL-COMPAREEU-21
• Status: Recruiting
• Phase: N/A
• First received: August 6, 2010
• Last updated: August 23, 2013
• Start date: September 2010

Study information

• Verified date: November 2010
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histological diagnosis of adenocarcinoma of the prostate on transrectal or transperineal template prostate biopsies

• Clinical stage = T2c N0 M0 (radiological T3a allowed)

• Local staging imaging as per guidelines to demonstrate localized disease (e.g., MRI, CT, and/or bone scan)

• No metastatic disease or nodal disease outside the prostate on bone scan or cross-sectional imaging

• No prior prostate surgery for cancer control (e.g., radical prostatectomy, high-intensity focused ultrasound ablation, cryosurgery, or photodynamic therapy) or other treatment for prostate cancer

• Gleason grade = 7

• Serum PSA = 15 ng/mL

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior radiotherapy

• No androgen suppression/hormone treatment within the previous 12 months for prostate cancer

Study Design

Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• informational intervention

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	University College of London Hospitals	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies			No
Primary	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			No
Secondary	Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics			No