Beyond PSA: The Role of Prostate Health Index (phi)

Ferro, Matteo; Cobelli, Ottavio De; Lucarelli, Giuseppe; Porreca, Angelo; Busetto, Gian Maria; Cantiello, Francesco; Damiano, Rocco; Autorino, Riccardo; Musi, Gennaro; Vartolomei, Mihai Dorin; Muto, Matteo; Terracciano, Daniela

doi:10.3390/ijms21041184

Cited by 57 publications

(56 citation statements)

References 67 publications

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“…Summarizing the available scientific data, it is concluded that phi and PHID could help to improve individual risk assessment for early particularly clinically significant PCa detection, to reduce unnecessary biopsies, either may help to select patients eligible for active surveillance and may play a role in treatment decision-making [32].…”

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confidence: 99%

Prostate Health Index and Prostate Health Index Density as Diagnostic Tools for Improved Prostate Cancer Detection

Barisiene

Bakavičius

Stanciute

et al. 2020

BioMed Research International

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Background. To evaluate the diagnostic potential of [-2] proPSA (p2PSA), %p2PSA, Prostate Health Index (phi), and phi density (PHID) as independent biomarkers and in composition of multivariable models in predicting high-grade prostatic intraepithelial neoplasia (HGPIN) and overall and clinically significant prostate cancer (PCa). Methods. 210 males scheduled for prostate biopsy with total PSA (tPSA) range 2-10 ng/mL and normal digital rectal examination were enrolled in the prospective study. Blood samples to measure tPSA, free PSA (fPSA), and p2PSA were collected immediately before 12-core prostate biopsy. Clinically significant PCa definition was based on Epstein’s criteria or ISUP grade≥2 at biopsy. Results. PCa has been diagnosed in 112 (53.3%) patients. Epstein significant and ISUP grade≥2 PCa have been identified in 81 (72.3%) and 40 (35.7%) patients, respectively. Isolated HGPIN at biopsy have been identified in 24 (11.4%) patients. Higher p2PSA and its derivative mean values were associated with PCa. At 90% sensitivity, PHID with cut-off value of 0.54 have demonstrated the highest sensitivity of 35.7% for overall PCa detection, so PHID and phi with cut-off values of 33.2 and 0.63 have demonstrated the specificity of 34.7% and 34.1% for ISUP grade≥2 PCa detection at biopsy, respectively. In univariate ROC analysis, PHID with AUC of 0.77 and 0.80 was the most accurate predictor of overall and Epstein significant PCa, respectively, so phi with AUC of 0.77 was the most accurate predictor of ISUP grade≥2 PCa at biopsy. In multivariate logistic regression analysis, phi improved diagnostic accuracy of multivariable models by 5% in predicting ISUP grade≥2 PCa. Conclusions. PHID and phi have shown the greatest specificity at 90% sensitivity in predicting overall and clinically significant PCa and would lead to significantly avoid unnecessary biopsies. PHID is the most accurate predictor of overall and Epstein significant PCa, so phi is the most accurate predictor of ISUP grade≥2 PCa. phi significantly improves the diagnostic accuracy of multivariable models in predicting ISUP grade≥2 PCa.

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confidence: 99%

Prostate Health Index and Prostate Health Index Density as Diagnostic Tools for Improved Prostate Cancer Detection

Barisiene

Bakavičius

Stanciute

et al. 2020

BioMed Research International

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“…Currently, FDA-approved assessments, including Progensa-PCA3 and prostate health index (PHI) tests, provide informative recommendations for repeated prostate biopsy among men with a previous negative biopsy [ 20 , 38 , 39 , 40 ]. The PHI test is also helpful in both reducing unnecessary initial biopsies in biopsy-naïve patients and predicting the pathological aggressiveness at radical prostatectomy [ 40 ]. Despite the above well-established instruments, we hope to identify additional biomarkers to improve the decision-making strategies.…”

Section: Discussionmentioning

confidence: 99%

Impact of H19 Polymorphisms on Prostate Cancer Clinicopathologic Characteristics

Lin

Wang

et al. 2020

Diagnostics

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Active surveillance is the preferred strategy for very low risk, low risk, and some favorable intermediate risk of prostate cancer. However, the current risk stratifications with initial prostate-specific antigen (iPSA) levels and Gleason scores at biopsy can underestimate the true oncologic threat. More precise predictors are required to avoid the overtreatment of prostate cancer. H19 single-nucleotide polymorphisms (SNPs) have been found to play crucial roles in numerous malignancies, but not yet in prostate cancer. This study assessed the clinicopathologic effects of H19 SNPs on prostate cancer to identify potential active surveillance candidates. A total of 579 patients with prostate cancer who underwent robot-assisted radical prostatectomy between 2012 and 2017 were recruited. The patients were grouped by iPSA levels, and five H19 SNPs were evaluated. Our results show that patients with an iPSA level of ≤7 ng/mL had increased an likelihood of having Gleason score and group grade upgrades after radical prostatectomy compared with patients with an iPSA level of >7 ng/mL. Moreover, patients with loci polymorphisms in either rs3024270 or rs3741219 had a significantly higher risk of perineural invasion (rs3024270: Odds ratio (OR) 2.76, 95% confidence interval (CI) 1.30–5.87, p = 0.01; rs3741219: OR 2.30, 95% CI 1.17–4.54, p = 0.018). In conclusion, our results suggested that H19 SNPs play a role in the perineural invasion of prostate cancer.

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“…It is now recommended by clinical guidelines for patients with elevated tPSA, especially for patients with tPSA between 2.0 and 10.0 ng/ml (4)(5)(6)(7). Synthesizing several published results, using phi can reduce the number of unnecessary biopsies with good sensitivity and detect clinically significant PCa; thus, phi might play an important role reducing overdiagnosis and overtreatment in urologic practice (8,9).…”

Section: Introductionmentioning

confidence: 99%

“…The cost of phi testing varies among different countries and regions from $35 to $370 (United States dollars) (9)(10)(11)(12)(13)(14). Several cost-effectiveness analyses of phi have been performed in the United States, Europe, and Hong Kong, which are all based on the population-based screening models using a specific phi cutoff (11,(14)(15)(16).…”

Section: Introductionmentioning

confidence: 99%

Cost-Effectiveness Analysis of Prostate Health Index in Decision Making for Initial Prostate Biopsy

Huang

Yang

et al. 2020

Front. Oncol.

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BackgroundClinical studies have suggested that prostate health index (phi) outperforms prostate-specific antigen (PSA) tests in prostate cancer detection. The cost-effectiveness of phi with different cutoffs is poorly understood in the context of decision making for prostate biopsy.MethodsIn a multicenter cohort, 3,348 men with elevated total PSA (tPSA) underwent initial prostate biopsy from August 2013 to May 2019. We constructed a decision model to evaluate the incremental cost-effectiveness ratios of different phi cutoffs. Total costs and reimbursement payments were based on the fee schedule of Shanghai Basic Medical Insurance and converted into United States dollars ($). Two willingness-to-pay thresholds were estimated as one or three times the average gross domestic product per capita of China ($7,760 or $23,279, respectively).ResultsThe total costs of prostate biopsy and PSA tests were estimated at $315 and $19, respectively. The cost of phi test varied between $72 to $130 in different medical centers. Under different phi cutoffs (from 23 to 35), phi test predicted reductions of 420 (21.7%) to 972 (50.2%) in unnecessary biopsies, with a total gain of 23.77–57.58 quality adjusted life-years compared to PSA tests. All the cutoffs would be cost-effective for patients with tPSA levels of 2–10 ng/ml. Applying 27 as the cutoff was cost-effective for each tPSA range, with missing positive cases ranging from 11 (3.4%) to 33 (11.5%).ConclusionsUsing phi test was cost-effective in the decision-making process for initial prostate biopsy, especially for patients with tPSA values between 2–10 ng/ml. The phi cutoff of 27 was cost-effective regardless of tPSA ranges and should be recommended from a health-economic perspective.

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Beyond PSA: The Role of Prostate Health Index (phi)

Cited by 57 publications

References 67 publications

Prostate Health Index and Prostate Health Index Density as Diagnostic Tools for Improved Prostate Cancer Detection

Prostate Health Index and Prostate Health Index Density as Diagnostic Tools for Improved Prostate Cancer Detection

Impact of H19 Polymorphisms on Prostate Cancer Clinicopathologic Characteristics

Cost-Effectiveness Analysis of Prostate Health Index in Decision Making for Initial Prostate Biopsy

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