Abstract
BackgroundDeciding when to biopsy a man with non-suspicious DRE findings and tPSA in the 4–10 ng/ml range can be challenging, because two-thirds of such biopsies are typically found to be benign. The Prostate Health Index (phi) exhibits significantly improved diagnostic accuracy for prostate cancer detection when compared to tPSA and %fPSA, however only one published study to date has investigated its impact on biopsy decisions in clinical practice.MethodsAn IRB approved observational study was conducted at four large urology group practices using a physician reported two-part questionnaire. Physician recommendations were recorded before and after receiving the phi test result. A historical control group was queried from each site's electronic medical records for eligible men who were seen by the same participating urologists prior to the implementation of the phi test in their practice. 506 men receiving a phi test were prospectively enrolled and 683 men were identified for the historical control group (without phi). Biopsy and pathological findings were also recorded for both groups.ResultsMen receiving a phi test showed a significant reduction in biopsy procedures performed when compared to the historical control group (36.4% vs. 60.3%, respectively, P < 0.0001). Based on questionnaire responses, the phi score impacted the physician’s patient management plan in 73% of cases, including biopsy deferrals when the phi score was low, and decisions to perform biopsies when the phi score indicated an intermediate or high probability of prostate cancer (phi ≥36).Conclusionsphi testing significantly impacted the physician’s biopsy decision for men with tPSA in the 4–10 ng/ml range and non-suspicious DRE findings. Appropriate utilization of phi resulted in a significant reduction in biopsy procedures performed compared to historical patients seen by the same participating urologists who would have met enrollment eligibility but did not receive a phi test.
Highlights
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.Prostate-specific antigen (PSA) screening for prostate cancer (PCa) has come under increasing scrutiny in recent years
The US Preventative Services Task Force (USPSTF) recommended against PSA screening for men of any age in 2012 [6], an updated draft recommendation statement was recently issued for public comment, wherein the USPSTF acknowledged that PSA testing may be appropriate for certain men in the 55–69 year age range (C-recommendation) [7]
92% of physician responses indicated that knowledge of the phi score was helpful when communicating their recommendation to the patient, including 28% of cases where a “reduced risk” phi score was helpful in alleviating the patient’s anxiety about the likelihood of significant cancer. This large study represents the only multicenter study to date investigating the impact of phi testing on biopsy decisions for patients presenting with elevated serum PSA and non-suspicious digital rectal exam (DRE) findings
Summary
Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.Prostate-specific antigen (PSA) screening for prostate cancer (PCa) has come under increasing scrutiny in recent years. The US Preventative Services Task Force (USPSTF) recommended against PSA screening for men of any age in 2012 [6], an updated draft recommendation statement was recently issued for public comment, wherein the USPSTF acknowledged that PSA testing may be appropriate for certain men in the 55–69 year age range (C-recommendation) [7] Another problem associated with PSA testing is its relatively poor diagnostic specificity. According to the National Comprehensive Cancer Network (NCCN), ~85% of men with PSA levels
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