Study of Treatment Choice in Patients With Localized Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: informational intervention
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: informational intervention|nan|
|Other: questionnaire administration|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between attributes important to men and baseline demographics, functional status, and disease risk characteristics |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer