Abstract
STUDY TYPE: Diagnostic (exploratory cohort). LEVEL OF EVIDENCE: 2b. OBJECTIVE: To evaluate the Prostate Cancer Prevention Trial (PCPT) risk calculator in a screening cohort of young, racially diverse, high-risk men with a low baseline prostate-specific antigen (PSA) level and enrolled in the Prostate Cancer Risk Assessment Program (PRAP). The PCPT calculator provides an assessment of prostate cancer risk based on age, PSA level, race, previous biopsy, and family history. PATIENTS AND METHODS: Eligibility for PRAP includes men aged 35-69 years who are African-American, have a family history of prostate cancer, or have a known BRCA1/2 mutation. PCPT risk scores were determined for PRAP participants, and were compared to observed prostate cancer rates. RESULTS: In all, 624 participants were evaluated, including 382 (61.2%) African-American men and 242 (38.7%) men with a family history of prostate cancer; the median (range) age was 49.0 (34.0-69.0) years and the median PSA level 0.9 (0.1-27.2) ng/mL. The PCPT risk score correlated with prostate cancer diagnosis, as the median baseline risk score in patients diagnosed with prostate cancer was 31.3%, vs 14.2% in patients not diagnosed with prostate cancer (P < 0.001). The PCPT calculator similarly stratified the risk of diagnosis of Gleason score > or =7 disease, as the median risk score was 36.2% in patients diagnosed with Gleason > or =7 prostate cancer vs 15.2% in all other participants (P < 0.001). CONCLUSION: The PCPT risk calculator score was found to stratify prostate cancer risk in a cohort of young, primarily African-American men with a low baseline PSA level. These results support further evaluation of this predictive tool for assessing the risk of prostate cancer in high-risk men.