Study of Treatment Choice in Patients With Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01177865
Recruitment Status : Unknown
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 9, 2010
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: informational intervention Other: questionnaire administration Not Applicable

Detailed Description:



  • 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.


  • 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Primary Purpose: Health Services Research
Official Title: Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment
Study Start Date : September 2010
Estimated Primary Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
  2. 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 :
  1. Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • 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


  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy
  • No androgen suppression/hormone treatment within the previous 12 months for prostate cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01177865

United Kingdom
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Contact Person    44-20-7380-9194   
Sponsors and Collaborators
University College London Hospitals
Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals Identifier: NCT01177865     History of Changes
Other Study ID Numbers: CDR0000682206
First Posted: August 9, 2010    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: November 2010

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases