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, 21 (1), 78-84

Clinical Utility of the Prostate Health Index (Phi) for Biopsy Decision Management in a Large Group Urology Practice Setting

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Clinical Utility of the Prostate Health Index (Phi) for Biopsy Decision Management in a Large Group Urology Practice Setting

Jay White et al. Prostate Cancer Prostatic Dis.

Abstract

Background: Deciding 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.

Methods: An 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.

Results: Men 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).

Conclusions: phi 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.

Conflict of interest statement

TER, DLB, LRL, MAR, CJP, and DD are employees of Beckman Coulter. The remaining authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Diagram demonstrating patient’s flow through the study protocol
Fig. 2
Fig. 2
Physician Decision Impact Questionnaire

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References

    1. Cooperberg MR, Moul JW, Carroll PR. The changing face of prostate cancer. J Clin Oncol. 2005;23:8146–51. - PubMed
    1. American Cancer Society. Cancer facts & Figures. 2014. (http://www.cancer.org/acs/groups/content/@research/documents/webcontent/acspc-042151.pdf.)
    1. Brett AS, Ablin RJ. Prostate-Cancer Screening - what the U.S. Preventive Services Task Force left out. N Engl J Med. 2011;365:1949–51. - PubMed
    1. Kim EH, Andriole GL. Prostate-specific antigen-based screening: controversy and guidelines. BMG Med. 2015;13:61–65. - PMC - PubMed
    1. Hayes JH, Barry MJ. Screening for prostate cancer with the Prostate-Specific Antigen Test. JAMA. 2014;311:1143–9. - PubMed

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