Performance of Prostate Health Index in Biopsy Naïve Black Men

Babajide, Rilwan; Carbunaru, Samuel; Nettey, Oluwarotimi; Watson, Karriem S.; Holloway‐Beth, Alfreda; McDowell, Tiffany; Levi, Josef Ben; Murray, Marcus; Stinson, James; Hollowell, Courtney M.P.; Dalton, Daniel P.; Moore, LeAndre; Kittles, Rick A.; Gann, Peter H.; Schaeffer, Edward M.

doi:10.1097/ju.0000000000001453

Cited by 15 publications

(13 citation statements)

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“…Finally, in a recent study, an AUC 0.63 was reported in Black people who were biopsy‐naïve with a PSA between 3 and 10, as in our cohort. The detection rate for Sig PCa was 38.5% in that report 25 …”

Section: Discussion/conclusionmentioning

confidence: 75%

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Prospective study of diagnostic accuracy in the detection of high‐grade prostate cancer in biopsy‐naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test

et al. 2021

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Objectives: This study aimed to externally validate the diagnostic accuracy of the Select MDx test for Significant prostate cancer (Sig PCa) (ISUP > 1), in a contemporaneous, prospective, multicenter cohort with a prostate-specific antigen (PSA) between 3 and 10 ng/ml and a non-suspicious digital rectal examination.Methods and Participants: For all enrolled patients, the Select Mdx test, the risk calculator ERSPC3 + DRE, and a prostatic magnetic resonance imaging (MRI) were carried out. Subsequently, a systematic 12-core trans-rectal biopsy and a targeted biopsy, in the case of a prostate imaging-reporting and data system (PIRADS) > 2 lesion (max three lesions), were performed. To assess the accuracy of the Select MDx test in the detection of clinically Sig PCa, the test sensitivity was evaluated.Secondary objectives were specificity, negative predictive value (NPV), positive predictive value (PPV), and area under the curve (AUC). A direct comparison with the ERSPC + DRE risk calculator and MRI were also performed. We also studied the predictive ability to diagnose Sig PCa from the combination of the Select MDx test with MRI using clinical decision-curve analysis.Results: There were 163 patients enrolled after meeting the inclusion criteria and study protocol. The Select MDx test showed a sensitivity of 76.9% (95% CI, 63.2-87.5), 49.6% specificity (95% CI, 39.9-59.2), 82.09% (95% CI, 70.8-90.4) NPV, and 41.67% (95% CI, 31.7-52.2) PPV for the diagnosis of Sig PCa. COR analysis was also performed, which showed an AUC of 0.63 (95% CI, 0.56-0.71). There were no differences in the accuracy of Select MDx, ERSPC + DRE, or MRI. The combination

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Section: Discussion/conclusionmentioning

confidence: 75%

“…The detection rate for Sig PCa was 38.5% in that report. 25 Potentially avoided biopsies is another important outcome to be evaluated. The Select MDX test avoided 53% of biopsies in a validation study, with only 5% Sig PCa missed.…”

Section: Discussion/conclusionmentioning

confidence: 99%

Prospective study of diagnostic accuracy in the detection of high‐grade prostate cancer in biopsy‐naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test

et al. 2021

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“…Treatment decision in localized PCa challenges patients and is, besides the goal of curing cancer, mainly based on therapy-related side-effects and patients’ preferences [ 18 , 19 ]. Consequently, patient-reported outcomes should be gathered and presented in a comprehensible manner.…”

Section: Discussionmentioning

confidence: 99%

Treatment decision satisfaction and regret after focal HIFU for localized prostate cancer

et al. 2020

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Purpose Focal therapies (FTs) are investigated within prospective studies on selected patients treated for localized prostate cancer (PCa). Benefits are preservation of genitourinary function and reduced complications, but follow-up is elaborate and is associated with uncertainty as cancer-free survival appears to be lower compared to standard radical treatments. The aim of this study was to analyse patient-reported acceptance of FT and evaluate factors associated with treatment decision regret. Methods 52 patients who received focal high-intensity focused ultrasound for low- to intermediate-risk PCa between 2014 and 2019 within two prospective trials were eligible for a survey regarding PCa-related treatment regret and quality-of-life (Clark’s scale) and the following potential predictors: sociodemographic variables, Charlson Comorbidity Index, subjective aging (AARC-10 SF), and general health-related quality-of-life (SF-12). Cancer persistence/recurrence (multiparametric MRI and fusion biopsy after 12 months) and functional outcomes (EPIC-26 UI/UIO/S) data were also included in this study. Results The overall survey response rate was 92.3% (48/52 patients). Median follow-up was 38 months (interquartile range = 25–50 months). In total, ten patients (20.8%) reported treatment decision regret. In univariable analyses, a clinically meaningful increase in urinary incontinence showed a significant association (OR 4.43; 95% CI 0.99–20.53; p = 0.049) with regret. Cancer recurrence (OR 12.31; 95% CI 1.78–159.26; p = 0.023) and general health worry as a domain of Clark’s scale (OR 1.07; 95% CI 1.03–1.14; p < 0.01) were predictors of regret in a multivariable logistic regression model (AUC = 0.892). Conclusion Acceptance of FT is comparable to standard treatments. Extensive follow-up including regular PSA testing does not cause additional regret but careful patient selection and information before FT is crucial.

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“…To assess the ability of PHI to detect Gleason grade 2-5 (GGG) PCa in African Americans, 158 patients with elevated PSA levels and 135 controls were recruited [32]. Results indicate that PHI ≥ 28.0 can be safely used to avoid unnecessary biopsies in African Americans.…”

Section: Phimentioning

confidence: 99%

“…To assess the ability of PHI to detect Gleason grade 2-5 (GGG) PCa in Black men, 158 patients with elevated PSA levels and 135 controls were recruited [32] (Table 2). With PSA ≥ 4.0 and PHI ≥ 35.0, 33.0% of unnecessary biopsies were avoided, but 17.3% of GGG 2-5 PCa were missed.…”

Section: Prostate Health Index (Phi)mentioning

confidence: 99%

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

Matuszczak

Schalken

Salagierski

2021

Cancers

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Prostate cancer (PCa) is the most common cancer in men worldwide. The current gold standard for diagnosing PCa relies on a transrectal ultrasound-guided systematic core needle biopsy indicated after detection changes in a digital rectal examination (DRE) and elevated prostate-specific antigen (PSA) level in the blood serum. PSA is a marker produced by prostate cells, not just cancer cells. Therefore, an elevated PSA level may be associated with other symptoms such as benign prostatic hyperplasia or inflammation of the prostate gland. Due to this marker’s low specificity, a common problem is overdiagnosis, which leads to unnecessary biopsies and overtreatment. This is associated with various treatment complications (such as bleeding or infection) and generates unnecessary costs. Therefore, there is no doubt that the improvement of the current procedure by applying effective, sensitive and specific markers is an urgent need. Several non-invasive, cost-effective, high-accuracy liquid biopsy diagnostic biomarkers such as Progensa PCA3, MyProstateScore ExoDx, SelectMDx, PHI, 4K, Stockholm3 and ConfirmMDx have been developed in recent years. This article compares current knowledge about them and their potential application in clinical practice.

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Performance of Prostate Health Index in Biopsy Naïve Black Men

Cited by 15 publications

References 0 publications

Prospective study of diagnostic accuracy in the detection of high‐grade prostate cancer in biopsy‐naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test

Prospective study of diagnostic accuracy in the detection of high‐grade prostate cancer in biopsy‐naïve patients with clinical suspicion of prostate cancer who underwent the Select MDx test

Treatment decision satisfaction and regret after focal HIFU for localized prostate cancer

Prostate Cancer Liquid Biopsy Biomarkers’ Clinical Utility in Diagnosis and Prognosis

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