Study of Treatment Choice in Patients With Localized Prostate Cancer - Full Text View

Sponsor:	University College London Hospitals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01177865

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:

MedlinePlus related topics: Cancer Prostate Cancer

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 23, 2012