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Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment


N/A
45 Years
80 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Evaluating Patient Preferences for the Treatment of Localized Prostate Cancer - A Discrete Choice Experiment


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Health Services Research

Outcome Measure:

Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies

Safety Issue:

No

Principal Investigator

Mark Emberton, MD, FRCS, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University College London Hospitals

Authority:

Unspecified

Study ID:

CDR0000682206

NCT ID:

NCT01177865

Start Date:

September 2010

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • Prostatic Neoplasms

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