Proclarix, A New Biomarker for the Diagnosis of Clinically Significant Prostate Cancer: A Systematic Review

Campistol, Míriam; Moróte, Juan; Regis, Lucas; Celma, Ana; Planas, Jacques; Trilla, E.

doi:10.1007/s40291-022-00584-4

Cited by 7 publications

(8 citation statements)

References 42 publications

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“…We selected the blood-based proteins of PHI and Proclarix tests as several authors showed that they were significantly associated with an increased risk for a positive biopsy and for a GS of ≥7 at RP [5,[20][21][22].…”

Section: Discussionmentioning

confidence: 99%

A Neural Network Model Combining [-2]proPSA, freePSA, Total PSA, Cathepsin D, and Thrombospondin-1 Showed Increased Accuracy in the Identification of Clinically Significant Prostate Cancer

Gentile

Civita

Ventura

et al. 2023

Cancers

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Background: The Prostate Health Index (PHI) and Proclarix (PCLX) have been proposed as blood-based tests for prostate cancer (PCa). In this study, we evaluated the feasibility of an artificial neural network (ANN)-based approach to develop a combinatorial model including PHI and PCLX biomarkers to recognize clinically significant PCa (csPCa) at initial diagnosis. Methods: To this aim, we prospectively enrolled 344 men from two different centres. All patients underwent radical prostatectomy (RP). All men had a prostate-specific antigen (PSA) between 2 and 10 ng/mL. We used an artificial neural network to develop models that can identify csPCa efficiently. As inputs, the model uses [-2]proPSA, freePSA, total PSA, cathepsin D, thrombospondin, and age. Results: The output of the model is an estimate of the presence of a low or high Gleason score PCa defined at RP. After training on a dataset of up to 220 samples and optimization of the variables, the model achieved values as high as 78% for sensitivity and 62% for specificity for all-cancer detection compared with those of PHI and PCLX alone. For csPCa detection, the model showed 66% (95% CI 66–68%) for sensitivity and 68% (95% CI 66–68%) for specificity. These values were significantly different compared with those of PHI (p < 0.0001 and 0.0001, respectively) and PCLX (p = 0.0003 and 0.0006, respectively) alone. Conclusions: Our preliminary study suggests that combining PHI and PCLX biomarkers may help to estimate, with higher accuracy, the presence of csPCa at initial diagnosis, allowing a personalized treatment approach. Further studies training the model on larger datasets are strongly encouraged to support the efficiency of this approach.

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Section: Discussionmentioning

confidence: 99%

A Neural Network Model Combining [-2]proPSA, freePSA, Total PSA, Cathepsin D, and Thrombospondin-1 Showed Increased Accuracy in the Identification of Clinically Significant Prostate Cancer

Gentile

Civita

Ventura

et al. 2023

Cancers

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“…Of note, only PCA3 and Polaris ® are FDA-approved for specific indications 21 . More recently, Proclarix showed better accuracy in detecting clinically significant PCa compared to free PSA percentage alone 22 , with its utility in clinical practice yet to be confirmed.…”

Section: Introductionmentioning

confidence: 99%

Proteomic-based stratification of intermediate-risk prostate cancer patients

Zhong

Sun

Aref

et al. 2023

Preprint

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Gleason grading is an important prognostic indicator for prostate adenocarcinoma and is crucial for patient treatment decisions. However, intermediate-risk patients diagnosed in Gleason Grade Groups (GG) 2 and GG3 can harbour either aggressive or non-aggressive disease, resulting in under- or over-treatment of a significant number of patients. Here, we performed proteomic, differential expression, machine learning, and survival analyses for 1,348 matched tumour and benign sample runs from 278 patients. Three proteins (F5, TMEM126B and EARS2) were identified as candidate biomarkers in patients with biochemical recurrence. Multivariate Cox regression yielded 18 proteins, from which a risk score was constructed to dichotomise prostate cancer patients into low- and high-risk groups. This 18-protein signature is prognostic for the risk of biochemical recurrence and completely independent of the intermediate GG. Our results suggest that markers generated by computational proteomic profiling have the potential for clinical applications including integration into prostate cancer management.

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“…[15][16][17][18][19][20][21][22] One limitation of the available literature on the Proclarix test is that all papers relied upon the results of a 10-14 core systematic biopsy of the prostate with or without targeted biopsy core. 15,[18][19][20] Although this practice is typical in the prostate cancer biomarker literature, concerns remain regarding the accuracy of this somewhat limited method of sampling the prostate. 6,23 For example, at the time of radical prostatectomy, up to 30% of patients will be upgraded or downgraded following a 12-14 core biopsy.…”

Section: Introductionmentioning

confidence: 99%

“…Proclarix (Proteomedix AG, Switzerland) is a novel serum‐based assay that was developed to aid in the risk stratification of men with an elevated PSA level 13 . This test, which incorporates serum total PSA (tPSA), free PSA (fPSA), cathepsin D (CTSD), thrombospondin 1 (THBS1) and patient age, 14 has been shown to detect csPCa with more favourable diagnostic performance characteristics as compared to percent fPSA (%fPSA) and the ERSPC risk calculator 15–22 . One limitation of the available literature on the Proclarix test is that all papers relied upon the results of a 10–14 core systematic biopsy of the prostate with or without targeted biopsy core 15,18–20 .…”

Section: Introductionmentioning

confidence: 99%

“…13 This test, which incorporates serum total PSA (tPSA), free PSA (fPSA), cathepsin D (CTSD), thrombospondin 1 (THBS1) and patient age, 14 has been shown to detect csPCa with more favourable diagnostic performance characteristics as compared to percent fPSA (%fPSA) and the ERSPC risk calculator. [15][16][17][18][19][20][21][22] One limitation of the available literature on the Proclarix test is that all papers relied upon the results of a 10-14 core systematic biopsy of the prostate with or without targeted biopsy core. 15,[18][19][20] Although this practice is typical in the prostate cancer biomarker literature, concerns remain regarding the accuracy of this somewhat limited method of sampling the prostate.…”

Section: Introductionmentioning

confidence: 99%

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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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Proclarix, A New Biomarker for the Diagnosis of Clinically Significant Prostate Cancer: A Systematic Review

Cited by 7 publications

References 42 publications

A Neural Network Model Combining [-2]proPSA, freePSA, Total PSA, Cathepsin D, and Thrombospondin-1 Showed Increased Accuracy in the Identification of Clinically Significant Prostate Cancer

A Neural Network Model Combining [-2]proPSA, freePSA, Total PSA, Cathepsin D, and Thrombospondin-1 Showed Increased Accuracy in the Identification of Clinically Significant Prostate Cancer

Proteomic-based stratification of intermediate-risk prostate cancer patients

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

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