Study of Treatment Choice in Patients With Localized Prostate Cancer

University College London Hospitals NHS Foundation Trust (UCLH)

Status: Unknown

Conditions: Prostate Cancer

Treatments: Other: informational intervention; Other: questionnaire administration

Study type: Interventional

Funder types: Other

Identifiers

NCT01177865

CDR0000682206

UCL-COMPARE

EU-21055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 432 estimated patients

Sex: Male

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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