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Study of Treatment Choice in Patients With Localized Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01177865
First received: August 6, 2010
Last updated: August 23, 2013
Last verified: November 2010

August 6, 2010
August 23, 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 [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01177865 on ClinicalTrials.gov Archive Site
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Primary Purpose: Health Services Research
Prostate Cancer
  • Other: informational intervention
  • Other: questionnaire administration
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
432
Not Provided
September 2012   (final data collection date for primary outcome measure)

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
Male
45 Years to 80 Years
No
United Kingdom
 
NCT01177865
CDR0000682206, UCL-COMPARE, EU-21055
Not Provided
Not Provided
University College London Hospitals
Not Provided
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