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The Prostate Health Index (phi)

phi is a more reliable method for screening prostate cancer, aiding in biopsy candidate selection. The test is indicated for men aged 50 years and older with total PSA between 4.0 and 10.0 ng/mL with a digital rectal examination (DRE) findings that are not suspicious for cancer.
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What is Prostate Health Index (phi)?

The Prostate Health Index (phi) is a prostate cancer risk assessment that improves early detection of prostate cancer and can help reduce unnecessary, negative prostate biopsies. Although prostate biopsies are a common procedure, they do carry the risks associated with any invasive medical procedure, and they can also be uncomfortable for the patient. phi incorporates the results of three blood tests—PSA, free PSA and p2PSA—to calculate a phi score. The phi score provides key information about the likelihood that patients with elevated PSA have cancer, as opposed to other, more benign conditions that can also cause elevated PSA scores. 

Key benefits of using phi

Greater accuracy and specificity

phi combines multiple prostate-specific biomarkers, providing a more accurate, specific and reliable indication of prostate health compared to traditional PSA tests1

Fewer unnecessary biopsies

By minimizing false positives, phi helps patients avoid unnecessary prostate biopsies, promoting patient comfort and minimizing risk while helping to reduce healthcare costs.2 If used in the correct population, phi can reduce the number of biopsies by up to 30%

Early detection

phi calculated a probability of prostate cancer to aid in early detection, contributing to timely intervention, increased options for treatment and improved patient outcomes.3 When prostate cancer is detected early, a patient’s 5-year survival rate is more than 99%4

Improved patient experience

With its precision and reliability, phi fosters trust and satisfaction among those seeking clear answers about their prostate health

Did you know?

phi is included in the 2023 National Comprehensive Cancer Network (NCCN) Guidelines for the early detection of prostate cancer.1

phi in action: Defer biopsies when introduced in routine clinical practice
 

A clinical study (Figure 1) comparing the treatment course of over 500 men assessed with phi to a historical control group—seen by the same urologists within the previous 24 months—showed:

  • The phi score significantly impacted the patient management plan in over 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)
  • Men receiving a phi test showed nearly a 24% reduction in the number of biopsy procedures performed compared to the historical control group with a decrease in the rates of low-grade (i.e., Gleason score 6) cancers detected. Moreover, the number of high-grade positive biopsies (Gleason score >7) did not change (Figure 1)

Figure 1: Real world biopsies and pathological findings before and after phi

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Prostate Health Index (phi) Profile

Prostate Health Index (phi). Total PSA measured. Free PSA and p2PSA reflex testing is performed when total PSA is between 4.0 and 10.0 ng/mL.*

*If reflex testing is performed, additional charges/CPT code(s) may apply

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References

  1. NCCN Guidelines® insights: prostate cancer early detection, version 1.2023. National Comprehensive Cancer Network. 2023
  2. Access p2PSA Instructions for Use. Beckman Coulter
  3. Loeb S, Sanda MG, Broyles DL, et al. The Prostate Health Index selectively identifies clinically significant prostate cancer. J Urol. 2015;193:1163-1169. doi:10.1016/j.juro.2014.10.121
  4. About prostate cancer. Zero Prostate Cancer. Accessed April 22, 2024. https://zerocancer.org/ about-prostate-cancer
  5. White J, Shenoy BV, Tutrone RF, et al. Clinical utility of the Prostate Health Index (phi) for biopsy decision management in a large group urology practice setting. Prostate Cancer Prostatic Dis. 2018;21(1):78-84. doi:10.1038/s41391-017-0008-7