Prostate Health Index (PHI)

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The Prostate Health Index (PHI) is a prediction model based on three prostate biomarkers that can accurately estimate the probability of (clinically significant) prostate cancer.

Research authors: William J. Catalona, Alan W. Partin, Martin G. Sanda, John T. Wei, George G. Klee, Chris H. Bangma, Kevin M. Slawin, Leonard S. Marks, Stacy Loeb, Dennis L. Broyles, Sanghyuk S. Shin, Amabelle B. Cruz, Daniel W. Chan, Lori J. Sokoll, William L. Roberts, Ron H. N. van Schaik, Isaac A. Mizrahi

Version: 1.0

Public
Urology
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V-1.0-10531.26.03.23

(01)08720938015175(8012)v1.0(4326)260323(240)10531

Download the User manual and consult the Intended purpose.

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The cut-off values and corresponding probabilities of (clinically significant) prostate cancer are derived from Catalona et al. (2011) using the Beckman Coulter Access Hybritech PSA Calibrators. Optimal cut-offs and probabilities differ between patient populations, such as (but not limited to) patients eligible for biopsy or radical prostatectomy, regions, PSA calibrators, and patient ethnicities. Please consult local clinical guidelines or external validation studies to choose the appropriate cut-off and probability.

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Calculations alone should never dictate patient care, and are no substitute for professional judgement. See our full disclaimer.

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Details

Algorithm author

T. A. Hueting

Algorithm ID

10531

Version

1.0.{{ model.microversion }}

Revision date

2026-03-23

Specialty

Oncology , Urology

Algorithm type

Custom calculation ^{(Calculation)}

MeSH terms

Prostate Cancer

Status

Public

Formula

Study characteristics

Additional information

The Prostate Health Index (PHI) is developed by Beckman Coulter and first validated by Jansen et al. (2010) and Catalona et al. (2011). Before the development of the Prostate Health Index (PHI), Prostate Antigen Serum (PSA) was commonly used as a screening in asymptomatic men. PSA with a cutoff at 4.0 ng/mL was used to decide if prostate biopsy was necessary or not. However, PSA may be confounded by benign conditions and showed therefore a low specificity. The Prostate Health Index (PHI) combines PSA, free PSA (the unbound form of PSA), and [-2]proPSA and is developed to increase the specificity in predicting PCa. The Prostate Health Index (PHI) is externally validated in many studies and demonstrated better performance in predicting prostate cancer compared to PSA serum alone. Here the data is provided on the most widely cited validation study, from Catalona et al. (2011),

Study Population

Total population size: 892

Continuous characteristics

Name	Mean	SD	Unit
Age \| Benign	62.6	7.0	Years
Age \| Cancer	63.0	7.1	Years
Prostate volume \| Benign	55.1	23.2	cc
Prostate Volume \| Cancer	44.3	19.4	cc
PSA \| Benign	5.3	1.9	ng/mL
PSA \| Cancer	5.4	1.9	ng/mL
fPSA \| Benign	1.0	0.5	ng/mL
fPSA \| Cancer	0.9	0.5	ng/mL
[-2]proPSA \| Benign	14.4	7.1	pg/mL
[-2]proPSA \| Cancer	16.8	11.1	pg/mL
%fPSA \| Benign	20.0	8.0	-
%fPSA \| Cancer	16.4	7.6	-
Prostate Health Index (PHI) \| Benign	33.9	15.0	-
Prostate Health Index (PHI) \| Cancer	49.2	31.3	-

Categorical characteristics

Name	Subset / Group	Nr. of patients
Oncology	Benign	462
Oncology	Cancer	430
Gleason Score \| 5	Cancer	1
Gleason Score \| 6	Cancer	289
Gleason Score \| 7	Cancer	119
Gleason Score \| 8	Cancer	9
Gleason Score \| 9	Cancer	11
Gleason Score \| Unknown	Cancer	1
Race \| Caucasian	Benign	361
Race \| Caucasian	Cancer	365
Race \| African-American	Benign	24
Race \| African-American	Cancer	9
Race \| Other	Benign	22
Race \| Other	Cancer	9
Race \| Unknown	Benign	55
Race \| Unknown	Cancer	34
Ethnicity \| Hispanic	Benign	14
Ethnicity \| Hispanic	Cancer	6
Ethnicity \| Not hispanic	Benign	187
Ethnicity \| Not hispanic	Cancer	153
Ethnicity \| Unknown	Benign	261
Ethnicity \| Unknown	Cancer	271

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Extra Information

	Evidencio B.V., Irenesingel 19, 7481 GJ Haaksbergen, The Netherlands
	V-1.0-10531.26.03.23
	(01)08720938015175(8012)v1.0(4326)260323(240)10531
	Download the User manual
	Medical device In vitro diagnostic medical device

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V-1.0-10531.26.03.23

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Study characteristics

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Study Population

Continuous characteristics

Categorical characteristics

Supporting Publications

Related files

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