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Study of Treatment Choice in Patients With Localized Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
informational intervention
questionnaire administration
Sponsored by
University College London Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University College of London HospitalsRecruiting

Outcomes

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
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

Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics

Full Information

First Posted
August 6, 2010
Last Updated
August 23, 2013
Sponsor
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01177865
Brief Title
Study of Treatment Choice in Patients With Localized Prostate Cancer
Official Title
Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University College London Hospitals

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
informational intervention
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
Title
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 Measure Information:
Title
Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Emberton, MD, FRCS, MBBS
Organizational Affiliation
University College London Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-20-7380-9194
Email
markemberton1@btinternet.com

12. IPD Sharing Statement

Learn more about this trial

Study of Treatment Choice in Patients With Localized Prostate Cancer

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