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2007 HSR&D National Meeting Abstract

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National Meeting 2007

3104 — Preferences and Reasons for Refusal to Participate in Prostate Cancer Treatment RCT

Wilt TJ (Minneapolis CCDOR) , Carlyle M (Minneapolis CCDOR), McKeehen D (Minneapolis CCDOR), Jones KM (Perry Point CSPCC)

The preferred method for treatment of localized prostate cancer is not known. We determined if willingness to participate in a randomized trial of prostate cancer treatment varied by race, age, and health status.

Survey responses were recorded from a registry of 13,223 newly diagnosed male veterans with localized prostate cancer from 43 Veterans Affairs Medical Centers screened for, and offered enrollment in VA-CSP#407 PIVOT: a randomized trial comparing radical prostatectomy (RP) to expectant management (EM) for localized prostate cancer. Men eligible but declining randomization were asked factors contributing to their decision. Demographic, self-reported health status, and tumor characteristics were recorded.

Among eligible men, 4283 (85%) declined randomization. Compared to randomized patients, those eligible but declined had similar characteristics regarding race, age, health status, tumor grade, and PSA level. Among eligible but declined, 37% selected (RP), 30% EM, and 20% radiation. Treatment selection varied by age, race, health status, tumor grade, and PSA. “Not willing to leave treatment decision to chance (68%)”, “fearing participation will interfere with proper treatment” (23%) and “physician preference” (17%) were the most common reasons for refusal. Reasons varied little according to race, age, tumor grade, or PSA level except as noted and even then absolute differences varied by less then 5-10%. Physician preference (p = 0.002 for younger vs. older men); Whites more likely then blacks to “fear participating would interfere with proper treatment” or the “others prefer they not participate” (p=.01); tumor grade and PSA level (higher = less likely to leave to chance).

Enrollment into prostate cancer randomized treatment trials is difficult. The majority of participants declined randomization due to concerns about the impact that the randomization process would have on their treatment. Reasons showed little variation according to age, race, health status, or histologic grade.

A better understanding and addressing of patient, physician, and family concerns regarding randomization may improve recruitment into critically needed randomized controlled trials of prostate cancer treatment.

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