PROPOSe: A Real-life Prospective Study of Proclarix, a Novel Blood-based Test to Support Challenging Biopsy Decision-making in Prostate Cancer

Steuber, Thomas; Heidegger, Isabel; Kafka, Mona; Roeder, M. Andreas; Chun, Felix K.‐H.; Preißer, Felix; Palisaar, Rein-Jüri; Hanske, Julian; Budaeus, Lars; Schiess, Ralph; Keller, Thomas; Semjonow, Axel; Hammerer, Peter; Manka, Lukas; Ecke, Thorsten; Schwentner, Christian; Ohlmann, Carsten

doi:10.1016/j.euo.2020.12.003

Cited by 16 publications

(28 citation statements)

References 21 publications

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“…However, the performance of these tools changed when analyzed by the PI-RADS category. The new marker Proclarix, which is very sensitive for csPCa [ 12 , 13 ], was the most efficient and clinically useful tool in men with PI-RADS ≤ 3. Proclarix increased the negative predictive value of mpMRI from 94% to 100%, while a prostate biopsy was required in 70% of men with negative mpMRI [ 4 , 5 ].…”

Section: Discussionmentioning

confidence: 99%

“…PSAD has been analyzed according to PI-RADS categories and different thresholds have been proposed depending on the results [ 10 ]. Currently, there is no ideal marker to use after mpMRI [ 11 ]; the new marker Proclarix might be an adequate candidate due to its high sensitivity for csPCa but has not yet been analyzed by PI-RADS category [ 12 , 13 ]. This test has recently been introduced, providing a risk score of csPCa from 1 to 100% with a cut-off at 10%, obtaining a high sensitivity and a high negative predictive value (90 and 95% respectively) [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

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Comparison of Proclarix, PSA Density and MRI-ERSPC Risk Calculator to Select Patients for Prostate Biopsy after mpMRI

Campistol

Morote

Triquell

et al. 2022

Cancers

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Tools to properly select candidates for prostate biopsy after magnetic resonance imaging (MRI) have usually been analyzed in overall populations with suspected prostate cancer (PCa). However, the performance of these tools can change regarding the Prostate Imaging-Reporting and Data System (PI-RADS) categories due to the different incidence of clinically significant PCa (csPCa). The objective of the study was to analyze PSA density (PSAD), MRI-ERSPC risk calculator (RC), and Proclarix to properly select candidates for prostate biopsy regarding PI-RADS categories. We performed a head-to-head analysis of 567 men with suspected PCa, PSA > 3 ng/mL and/or abnormal rectal examination, in whom two to four core transrectal ultrasound (TRUS) guided biopsies to PI-RADS ≥ three lesions and/or 12-core TRUS systematic biopsies were performed after 3-tesla mpMRI between January 2018 and March 2020 in one academic institution. The overall detection of csPCa was 40.9% (6% in PI-RADS < 3, 14.8% in PI-RADS 3, 55.3% in PI-RADS 4, and 88.9% in PI-RADS 5). MRI-ERSPC model exhibited a net benefit over PSAD and Proclarix in the overall population. Proclarix outperformed PSAD and MRI-ERSPC RC in PI-RADS ≤ 3. PSAD outperformed MRI-ESRPC RC and Proclarix in PI-RADS > 3, although none of them exhibited 100% sensitivity for csPCa in this setting. Therefore, tools to properly select candidates for prostate biopsy after MRI must be analyzed regarding the PI-RADS categories. While MRI-ERSPC RC outperformed PSAD and Proclarix in the overall population, Proclarix outperformed in PI-RADS ≤ 3, and no tool guaranteed 100% detection of csPCa in PI-RADS 4 and 5.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Comparison of Proclarix, PSA Density and MRI-ERSPC Risk Calculator to Select Patients for Prostate Biopsy after mpMRI

Campistol

Morote

Triquell

et al. 2022

Cancers

View full text Add to dashboard Cite

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“…The new marker Proclarix has been associated with PCa grading, but used to compare men without PCa or GG 1 with those with GG 2 or 3 and those with GG 4 or 5 [ 10 21 ]. The present study confirms that Proclarix score is associated with the GG, but it cannot distinguish between GG 2 and GG 3.…”

Section: Discussionmentioning

confidence: 99%

“…Nowadays, only the recently published PROPOSe study has analyzed the relationship between Proclarix score and the results of mpMRI. The authors analyze the biopsy results in 121 men with positive mpMRI, suggesting that Proclarix represents a valuable rule-out test in the diagnostic algorithm for PCa, alone or in combination with mpMRI [ 21 ].…”

Section: Discussionmentioning

confidence: 99%

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The Efficacy of Proclarix to Select Appropriate Candidates for Magnetic Resonance Imaging and Derived Prostate Biopsies in Men with Suspected Prostate Cancer

Morote

Campistol

Celma

et al. 2022

World J Mens Health

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Purpose To analyze how Proclarix is valuable to appropriately select candidates for multiparametric magnetic resonance imaging (mpMRI) and derived biopsies, among men with suspected prostate cancer (PCa). Proclarix is a new marker computing the clinically significant PCa (csPCa) risk, based on serum thosmbospondin-1, cathepsin D, prostate-specific antigen (PSA) and percent free PSA, in addition to age, that has been developed in men with serum PSA 2 to 10 ng/mL, prostate volume ≥35 mL, and normal digital rectal examination (DRE). Materials and Methods Proclarix score (0%–100%) is analyzed in a prospective frozen serum collection of 517 correlative men scheduled for guided and/or systematic biopsies after mpMRI. Outcome variables were csPCa detection (grade group ≥2), insignificant PCa (iPCa) overdetection and avoided mpMRIs. Results The area under the curve of Proclarix was 0.701 (95% CI 0.637–0.765) among 281 men with serum PSA 2 to 10 ng/mL, prostate volume ≥35 mL, and -normal DRE, and 0.754 (95% CI 0.701–0.807) in the others, p=0.038. Net benefit of Proclarix existed in all men. After selecting 10% threshold, Proclarix was integrated in an algorithm which also used the serum PSA level and DRE. A reduction of 25.4% of mpMRIs request was observed and 17.7% of prostate biopsies. Overdetection of iPCa was reduced in 18.2% and 2.6% of csPCa were misdiagnosed. Conclusions Proclarix is valuable in all men with suspected PCa. An algorithm integrating Proclarix score, serum PSA, and DRE can avoid mpMRI requests, unnecessary prostate biopsies and iPCa overdetection, with minimal loss of csPCa detection.

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Evaluation of Proclarix in the diagnostic work‐up of prostate cancer

Kaufmann,

Fischer,

Athanasiou

et al. 2023

BJUI Compass

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ObjectivesThe use of multiparametric magnetic resonance imaging (mpMRI) has been widely adopted in the diagnostic work‐up for suspicious prostate cancer (PCa) and is recommended in most current guidelines. However, mpMRI lesions are often indeterminate and/or turn out to be false‐positive on prostate biopsy. The aim of this work was to evaluate Proclarix, a biomarker test for the detection of relevant PCa, regarding its diagnostic value in all men before biopsy and in men with indeterminate lesions on mpMRI (PI‐RADS 3) during work‐up for PCa.Materials and MethodsMen undergoing mpMRI‐targeted and systematic biopsy of the prostate were prospectively enrolled. The Proclarix test was evaluated for the detection accuracy of clinically significant PCa (csPCa) defined as Grade Group ≥ 2 and its association to mpMRI results. Further, Proclarix's performance was also tested when adapted to prostate volume (Proclarix density) and performance compared to PSA density (PSAD).ResultsA total of 150 men with a median age of 65 years and median PSA of 5.8 ng/mL were included in this study. CsPCa was diagnosed in 65 (43%) men. Proclarix was significantly associated with csPCa and higher PI‐RADS score (p < 0.001). At the pre‐defined cut‐off of 10%, Proclarix's sensitivity for csPCa was 94%, specificity 19%, negative predictive value 80% and positive predictive value 47%. Proclarix density showed the highest AUC for the detection of csPCa of 0.77 (95%CI: 0.69–0.85) compared to PSA, PSAD and Proclarix alone. Proclarix was able to identify all six csPCa in men with PI‐RADS 3 lesions (n = 28), whereas PSAD missed two out of six. At optimized cut‐offs, Proclarix density outperformed PSAD by potentially avoiding 41% of unnecessary biopsies.ConclusionProclarix demonstrates high sensitivity in detecting csPCa but may still result in unnecessary biopsies. However, Proclarix density was able to outperform PSAD and Proclarix and was found to be useful in men with PI‐RADS 3 findings by safely avoiding unnecessary biopsies without missing csPCa.

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PROPOSe: A Real-life Prospective Study of Proclarix, a Novel Blood-based Test to Support Challenging Biopsy Decision-making in Prostate Cancer

Cited by 16 publications

References 21 publications

Comparison of Proclarix, PSA Density and MRI-ERSPC Risk Calculator to Select Patients for Prostate Biopsy after mpMRI

Comparison of Proclarix, PSA Density and MRI-ERSPC Risk Calculator to Select Patients for Prostate Biopsy after mpMRI

The Efficacy of Proclarix to Select Appropriate Candidates for Magnetic Resonance Imaging and Derived Prostate Biopsies in Men with Suspected Prostate Cancer

Evaluation of Proclarix in the diagnostic work‐up of prostate cancer

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