SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy: A Prospective Assessment in a Multi-Institutional Study
Abstract
:Simple Summary
Abstract
1. Introduction
2. Material and Methods
2.1. Study Population
2.2. mpMRI
2.3. SelectMDx Sampling
2.4. Prostatic Biopsy
2.5. Statistical Analysis
3. Results
3.1. SelectMDx Performance for PCa and csPCa at Biopsy
3.2. Impact of Implementation of SelectMDx Versus PSAD into the mpMRI Pathway to Select Patients Candidate for Prostate Biopsy
3.3. Impact of Different Screening Strategies to Select Patients Candidate for Prostate Biopsy
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Parameter | Negative PCa | All PCa | csPCa | p-Value * | p-Value ** |
---|---|---|---|---|---|
Number of cases n (%) | 206 (66.5) | 104 (33.5) | 62 (20.0) | ||
Age (years) | |||||
mean ± SD | 64 ± 7.7 | 64 ± 8.2 | 63 ± 9.0 | 0.691 | 0.518 |
median | 65 | 65 | 64 | ||
range | 44–79 | 45–79 | 45–79 | ||
Total PSA (ng/mL) | |||||
Mean ± SD | 6.9 ± 4.1 | 9.0 ± 4.3 | 9.5 ± 5.0 | <0.0001 | 0.0001 |
median | 6.1 | 8 | 8.1 | ||
range | 1.0–19.5 | 1.0–19.9 | 1.2–19.9 | ||
PSAD (ng/mL/mL) | |||||
Mean ± SD | 0.13 ± 0.08 | 0.18 ± 0.11 | 0.18 ± 0.12 | <0.0001 | 0.0001 |
median | 0.1 | 0.15 | 0.16 | ||
range | 0.02–0.36 | 0.02–0.53 | 0.02–0.53 | ||
SelectMDx score, n (%) | |||||
negative | 152 (73.8) | 14 (13.5) | 8 (12.9) | <0.0001 | <0.0001 |
positive | 54 (26.2) | 90 (86.5) | 54 (87.1) | ||
probability for csPCa (%) | |||||
mean ± SD | 6.9 ± 13.9 | 25.9 ± 18.2 | 27.7 ± 18.1 | <0.0001 | <0.0001 |
median (range) | 0(0–62) | 24.0(0–81) | 25.0(0–81) | ||
mpMRI PI-RADS score, n (%) | |||||
PI-RADS 1–2 | 160 (77.7) | 18 (17.3) | 10 (16.1) | <0.0001 | <0.0001 |
PI-RADS 3 | 22 (10.7) | 32 (30.8) | 14 (22.6) | ||
PI-RADS 4–5 | 24 (11.6) | 54 (51.9) | 38 (61.3) | ||
SelectMDx score and | |||||
mpMRI PI-RADS score, n (%) | |||||
SelectMDx positive, mpMRI positive | 6 (2.9) | 48 (46.2) | 34 (54.8) | 0.001 | <0.0001 |
SelectMDx negative, mpMRI negative | 134 (65.0) | 8 (7.7) | 4 (6.5) | ||
SelectMDx positive, mpMRI negative | 48 (23.4) | 42 (40.4) | 20 (32.2) | 0.008 | <0.0001 |
SelectMDx negative, mpMRI positive | 18 (8.7) | 6 (5.7) | 4 (6.5) |
Parameter | All PCa | csPCa | ||||||
---|---|---|---|---|---|---|---|---|
Sensitivity | Specificity | NPV | PPV | Sensitivity | Specificity | NPV | PPV | |
SelectMDx | 86.5 (78.5–91.9) | 73.8 (64.7–79.3) | 91.6 | 62.5 | 87.1 (76.2–93.5) | 63.7 (57.5–69.4) | 95.2 | 37.5 |
mpMRI PI-RADS | 51.9 (42.4–61.3) | 88.3 (83.2–92.1) | 78.4 | 69.2 | 61.3 (48.8–72.4) | 83.9 (78.7–87.9) | 89.7 | 48.7 |
mpMRI PI-RADS and SelectMDx | 46.2 (36.9–55.7) | 97.1 (93.6–98.8) | 78.1 | 88.9 | 54.8 (42.5–66.6) | 91.9 (87.8–94.8) | 89.1 | 63.0 |
mpMRI PI-RADS and total PSA | 50.0 (40.6–59.4) | 90.3 (85.4–93.7) | 78.2 | 72.2 | 58.1 (45.7–69.5) | 85.5 (80.5–89.3) | 89.1 | 50.0 |
mpMRI PI-RADS and total PSAD | 38.5 (29.7–48.1) | 95.1 (91.1–97.4) | 75.4 | 80.0 | 45.2 (33.4–57.5) | 91.1 (86.9–94.1) | 86.9 | 56.0 |
Strategy | Avoided Biopsies, n (%) | PCa, n (%) | csPCa, n (%) | ||
---|---|---|---|---|---|
n= 310 | n = 104 | n = 62 | |||
Detected | Missed | Detected | Missed | ||
strategy 1 | 166 (53.5) | 90 (86.5) | 14 (13.5) | 54 (87.1) | 8 (12.9) |
strategy 2 | 178 (57.4) | 86 (82.7) | 18 (17.3) | 52 (83.9) | 10 (16.1) |
strategy 3 | 232 (74.8) | 54 (51.9) | 50 (48.1) | 38 (61.3) | 24 (38.7) |
strategy 4 | 220 (71.0) | 74 (71.1) | 30 (28.9) | 46 (74.2) | 16 (25.8) |
strategy 5 | 256 (82.6) | 48 (46.1) | 116 (53.9) | 34 (54.8) | 28 (45.2) |
strategy 6 | 124 (40.0) | 102 (98.1) | 2 (1.9) | 60 (96.8) | 2 (3.2) |
strategy 7 | 142 (45.8) | 96 (92.3) | 8 (7.7) | 58 (93.5) | 6 (6.5) |
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Maggi, M.; Del Giudice, F.; Falagario, U.G.; Cocci, A.; Russo, G.I.; Di Mauro, M.; Sepe, G.S.; Galasso, F.; Leonardi, R.; Iacona, G.; et al. SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy: A Prospective Assessment in a Multi-Institutional Study. Cancers 2021, 13, 2047. https://doi.org/10.3390/cancers13092047
Maggi M, Del Giudice F, Falagario UG, Cocci A, Russo GI, Di Mauro M, Sepe GS, Galasso F, Leonardi R, Iacona G, et al. SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy: A Prospective Assessment in a Multi-Institutional Study. Cancers. 2021; 13(9):2047. https://doi.org/10.3390/cancers13092047
Chicago/Turabian StyleMaggi, Martina, Francesco Del Giudice, Ugo G. Falagario, Andrea Cocci, Giorgio Ivan Russo, Marina Di Mauro, Giuseppe Salvatore Sepe, Fabio Galasso, Rosario Leonardi, Gabriele Iacona, and et al. 2021. "SelectMDx and Multiparametric Magnetic Resonance Imaging of the Prostate for Men Undergoing Primary Prostate Biopsy: A Prospective Assessment in a Multi-Institutional Study" Cancers 13, no. 9: 2047. https://doi.org/10.3390/cancers13092047