Table 2.
Patient-Based Histologic Biopsy Outcomes by Fusion Platform
| MRI |
Biopsy Results |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Fusion System – Trade Name (Manufacturer) |
Principle Investigator Location |
Patient Inclusion Criteria |
Defining Lesion Suspicion for PCa |
# of Patients with MR Suspicious Lesions |
Cancer Detection in Patients with MR Lesion (# of Patients) |
Cancer Detection (TB) |
Cancer Detection (SB) |
p- value |
Additional/Notable Study Conclusions |
| UroNav (In Vivo/Philips) | Bethesda, USA [36-39] | August 2007-August 2012 | Low, moderate, or high | Low - 123 (21%); Moderate - 370 (64%); High - 89 (15%) | 315/582 (54%) | 253/315 (80%) pts | 255/315 (81%) pts | --- | TB upgrades and detects higher Gleason score in 36% of patients compared with TRUS. Lesions with high suspicion on mpMRI associated with higher rate of Gleason upgrading on target vs 12 core biopsy |
| Artemis (Eigen) | Los Angeles, USA [40-41] | March 2010-September 2011. | Score 1 to 5 (normal to highly suspicious) | 151/171 (88%) | 84/151 (56%) | 101/486 (20.8%) cores. | 127/174 1 (7.3%) cores | 0.001 | TB is three times more likely to identify disease than SB (20.8% vs 7.3%, p=0.001) with greater detection of intermediate to high risk disease (36% vs 24%, p=0.037)Biopsy findings correlate with level of MR suspicion. |
| Urostation (Koelis) | Paris, France [34] | January 2011 - March 2012. | Yes/No | 82/133 (62%) | 71/82 (87%) | 62/82 (76%) patients | 44/133 (33%) patients | --- | TB cancer detection was sig higher than SB (p = 0.0016). Cognitive TB no diff from SB (= 0.66) |
| Oslo, Norway [43] | December 2010 - May 2011. | Low, medium, or high | 80/90 (89%) patients. Lesions - High (55), Medium (6), Low (4) | 54/80 (67.5%) | 60/115 (52%) Targets. | 6/42 (14%) patients | --- | 10 pts neg MRI all neg RB. 112/115 (97%) MR targets successful, 50/115 (52%) positive for cancer. | |
| Grenoble, France [44] | November 2011 - August 2012. | Prostate Imaging-Reporting and Data System (PI-RADS) | 20/30 (67%) | 11/20 (55%) | --- | --- | --- | Urostation has good accuracy for targeting suspicious areas on MRI | |
| BiopSee (Pi Medical/MedCom) | Heidelberg, Germany [45] | June 2010 - December 2011. | Highly suspicious, Questionable, or not suspicious | Highly suspicious -104/347 (30%); Questionable - 149 (43%) ; Not suspicious -94 (27%) | Overall - 200/347 (58% pts). Highly suspicious -(82.6% pts). Questionable - (67% pts). Not suspicious (14.8% pts). | 386/1281 (30%) cores | 523/632 6 (8.2%) cores | 0.01 | TB detect significantly more cancer than SB (30% vs 8.2%) p = 0.01 and of greater significance (41% had significant PCa).Patients without cancer-suspicious MR lesions, 11.7% (11/94) were diagnosed with intermediate risk disease. 50.6% pts (152/300) patients reported mild hematuria, 26% temporary erectile dysfunction. |
| Virtual Navigator (Esaote) | Paris, France [34] | January 2011 - March 2012. | Yes/No | 78/131 (59%) | 78/78 (100%) | 64/78 (82%) patients | 60/131 (46%) patients | --- | Rigid system TB were sig higher than RB (p = 0.0065). Cognitive TB no diff from RB (= 0.66) |
| Lille, France [33] | May 2009 - January 2011 | 1-5 (Unlikely to highly likely) | 95/95 (100%) | --- | 66/95 (69%) patients *combination of cognitive and Vnav fusion cores | 56/95 (56%) patients | 0.033 | Clinically significant PCa 49/95 (52%) SB patients, 64/95 (67%) TB patients (p = 0.0011). Cognitive vs Platform fusion no significant different in cancer detection or Gleason score assessment (47% vs 53%, p = 0.16) | |
| HI RVS/Real-Time Virtual Sonography (Hitachi) | Chiba, Japan [46] | February 2007-August 2009. | Yes/No | 85/85 (100%) | 52/85 (61%) | 62/192 (32%) cores | 75/833 (9%) cores | <0.01 | TB cores revealed more cancer than SB (32% vs 9%, p < 0.01) |