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)

August 6, 2010
August 9, 2010
August 26, 2013
September 2010
September 2012   (Final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01177865 on Archive Site
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
Same as current
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Study of Treatment Choice in Patients With Localized Prostate Cancer
Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment

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.



  • 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.

Not Applicable
Primary Purpose: Health Services Research
Prostate Cancer
  • Other: informational intervention
  • Other: questionnaire administration
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
September 2012   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: Male
45 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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University College London Hospitals
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Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
National Cancer Institute (NCI)
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP