Thomas Steuber1, Isabel Heidegger2, Mona Kafka2, Martin A Roeder3, Felix Chun4, Felix Preisser4, Rein-Jüri Palisaar5, Julian Hanske5, Lars Budaeus6, Ralph Schiess7, Thomas Keller8, Axel Semjonow9, Peter Hammerer10, Lukas Manka10, Thorsten Ecke11, Christian Schwentner12, Carsten Ohlmann13. 1. Martini-Klinik, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Electronic address: steuber@uke.de. 2. Medical University Innsbruck, Department of Urology, Innsbruck, Austria. 3. Copenhagen Prostate Cancer Centre, Department of Urology, Rigshospitalet Copenhagen, Copenhagen, Denmark. 4. University Hospital Frankfurt, Department of Urology, Frankfurt, Germany. 5. Department of Urology, Marien Hospital Herne, Ruhr-University Bochum, Herne, Germany. 6. Martini-Klinik, University Hospital Hamburg-Eppendorf, Hamburg, Germany. 7. Proteomedix AG, Zurich-Schlieren, Switzerland. 8. ACOMED statistik, Leipzig, Germany. 9. University Hospital Muenster, Dept. of Urology, Prostate Centre, Muenster, Germany. 10. Academic Hospital Braunschweig, Braunschweig, Germany. 11. Helios Hospital Bad Saarow, Bad Saarow, Germany. 12. Diakonie-Klinikum Stuttgart, Stuttgart, Germany. 13. Johanniter Krankenhaus Bonn, Department of Urology, Bonn, Germany.
Abstract
BACKGROUND: Prostate-specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa, more frequently in the PSA range of 2-10 ng/ml, in men with increased prostate volume and normal digital rectal examination (DRE). OBJECTIVE: This study evaluated the accuracy of Proclarix, a novel blood-based diagnostic test, to help in biopsy decision-making in this challenging patient population. DESIGN, SETTING, AND PARTICIPANTS: Ten clinical sites prospectively enrolled 457 men presenting for prostate biopsy with PSA between 2 and 10 ng/ml, normal DRE, and prostate volume ≥35 cm3. Transrectal ultrasound-guided and multiparametric magnetic resonance imaging (mpMRI)-guided biopsy techniques were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Serum samples were tested blindly at the end of the study. Diagnostic performance of Proclarix risk score was established in correlation to systematic biopsy outcome and its performance compared with %free PSA (%fPSA) and the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) as well as Proclarix density compared with PSA density in men undergoing mpMRI. RESULTS AND LIMITATIONS: The sensitivity of Proclarix risk score for clinically significant PCa (csPCa) defined as grade group (GG) ≥2 was 91% (n = 362), with higher specificity than both %fPSA (22% vs 14%; difference = 8% [95% confidence interval {CI}, 2.6-14%], p = 0.005) and RC (22% vs 15%; difference = 7% [95% CI, 0.7-12%], p = 0.028). In the subset of men undergoing mpMRI-fusion biopsy (n = 121), the specificity of Proclarix risk score was significantly higher than PSA density (26% vs 8%; difference = 18% [95% CI, 7-28%], p < 0.001), and at equal sensitivity of 97%, Proclarix density had an even higher specificity of 33% [95% CI, 23-43%]. CONCLUSIONS: In a routine use setting, Proclarix accurately discriminated csPCa from no or insignificant PCa in the most challenging patients. Proclarix represents a valuable rule-out test in the diagnostic algorithm for PCa, alone or in combination with mpMRI. PATIENT SUMMARY: Proclarix is a novel blood-based test with the potential to accurately rule out clinically significant prostate cancer, and therefore to reduce the number of unneeded biopsies.
BACKGROUND: Prostate-specific antigen (PSA)-based detection of prostate cancer (PCa) often leads to negative biopsy results or detection of clinically insignificant PCa, more frequently in the PSA range of 2-10 ng/ml, in men with increased prostate volume and normal digital rectal examination (DRE). OBJECTIVE: This study evaluated the accuracy of Proclarix, a novel blood-based diagnostic test, to help in biopsy decision-making in this challenging patient population. DESIGN, SETTING, AND PARTICIPANTS: Ten clinical sites prospectively enrolled 457 men presenting for prostate biopsy with PSA between 2 and 10 ng/ml, normal DRE, and prostate volume ≥35 cm3. Transrectal ultrasound-guided and multiparametric magnetic resonance imaging (mpMRI)-guided biopsy techniques were allowed. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Serum samples were tested blindly at the end of the study. Diagnostic performance of Proclarix risk score was established in correlation to systematic biopsy outcome and its performance compared with %free PSA (%fPSA) and the European Randomised Study of Screening for Prostate Cancer (ERSPC) risk calculator (RC) as well as Proclarix density compared with PSA density in men undergoing mpMRI. RESULTS AND LIMITATIONS: The sensitivity of Proclarix risk score for clinically significant PCa (csPCa) defined as grade group (GG) ≥2 was 91% (n = 362), with higher specificity than both %fPSA (22% vs 14%; difference = 8% [95% confidence interval {CI}, 2.6-14%], p = 0.005) and RC (22% vs 15%; difference = 7% [95% CI, 0.7-12%], p = 0.028). In the subset of men undergoing mpMRI-fusion biopsy (n = 121), the specificity of Proclarix risk score was significantly higher than PSA density (26% vs 8%; difference = 18% [95% CI, 7-28%], p < 0.001), and at equal sensitivity of 97%, Proclarix density had an even higher specificity of 33% [95% CI, 23-43%]. CONCLUSIONS: In a routine use setting, Proclarix accurately discriminated csPCa from no or insignificant PCa in the most challenging patients. Proclarix represents a valuable rule-out test in the diagnostic algorithm for PCa, alone or in combination with mpMRI. PATIENT SUMMARY: Proclarix is a novel blood-based test with the potential to accurately rule out clinically significant prostate cancer, and therefore to reduce the number of unneeded biopsies.
Authors: Miriam Campistol; Juan Morote; Marina Triquell; Lucas Regis; Ana Celma; Inés de Torres; María E Semidey; Richard Mast; Anna Santamaría; Jacques Planas; Enrique Trilla Journal: Cancers (Basel) Date: 2022-05-30 Impact factor: 6.575
Authors: Juan Morote; Miriam Campistol; Marina Triquell; Anna Celma; Lucas Regis; Inés de Torres; Maria E Semidey; Richard Mast; Anna Santamaria; Jacques Planas; Enrique Trilla Journal: Eur Urol Open Sci Date: 2022-01-23
Authors: Juan Morote; Miriam Campistol; Anna Celma; Lucas Regis; Inés de Torres; María E Semidey; Sarai Roche; Richard Mast; Anna Santamaría; Jacques Planas; Enrique Trilla Journal: World J Mens Health Date: 2021-12-27 Impact factor: 5.400