Minority recruitment in the prostate cancer prevention trial

PURPOSE: African American men have a higher prostate cancer risk profile th an that of other men in the United States. The purpose of this manuscript i s to summarize the challenges associated with enrolling and randomizing Afr ican American and other minority participants in the Prostate Cancer Preven tion Trial (PCPT). METHODS: The PCPT is a randomized trial of finasteride versus placebo for p reventing prostate cancer in healthy men age 55 years and older; it is coor dinated by the Southwest Oncology Group. The manuscript describes demograph ic and lifestyle characteristics of the PCPT randomized sample (18,882 men) by four racial and ethnic groups (Caucasian, African American, Hispanic, a nd other). African American men comprised 4% of the total randomized sample compared to our goal of 8%. Minority recruitment was emphasized through th e Study Manual and training that occurred at trial activation. Supplemental minority recruitment activities were initiated a year after study activati on and continued through the end of the accrual period. Minority recruitmen t was emphasized as follows: minority recruitment presentations at PCPT tra ining seminars (held during twice yearly Southwest Oncology Group meetings) ; distribution of additional minority recruitment materials; engagement of four consultants for minority recruitment; production of a Minority Recruit ment Manual; and a small pilot study involving minority outreach recruiters at five PCPT sites. RESULTS: The consultants were helpful in implementing the pilot project and in suggesting and reviewing materials for minority recruitment. The five-s ite pilot project did not increase either enrollment or randomization of mi norities (with a possible exception at one site). CONCLUSIONS: We suggest that a long term perspective is required for succes sful recruitment of minority participants in clinical trials. Likewise, ext ensive minority recruitment efforts must be ready to implement at trial act ivation. (C) 2000 Elsevier Science Inc. All rights reserved.