Clinical trial NCT01177865: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2010-08-09
Enrollment: 432
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Preferences for, and trade-offs between, the attributes of pre-treatment evaluation with general anaesthetic biopsies and post-treatment frequency of biopsies
measure: 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 outcomes:
measure: Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
Study officials:
affiliation: University College London Hospitals
name: Mark Emberton, MD, FRCS, MBBS
role: PRINCIPAL_INVESTIGATOR
References: