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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: February 18, 2011
Last verified: November 2010
History of Changes
  Purpose

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 Intervention
Prostate Cancer
 Other: informational intervention
Other: questionnaire administration

Study Type: Interventional
Study Design: Primary Purpose: Health Services Research
Official Title: Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics [ Designated as safety issue: No ]

Estimated Enrollment: 432
Study Start Date: September 2010
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177865

Locations
United Kingdom
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Contact Person     44-20-7380-9194     markemberton1@btinternet.com    
Sponsors and Collaborators
University College London Hospitals
Investigators
Principal Investigator: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT01177865     History of Changes
Other Study ID Numbers: CDR0000682206, UCL-COMPARE, EU-21055
Study First Received: August 6, 2010
Last Updated: February 18, 2011
Health Authority: Unspecified

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
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013