TABLE 1.
Characteristics of Hemiablation Candidates in the Primary Analysis
| Total N = 92 | Discordant N = 44 | Concordant N = 48 | P | |
|---|---|---|---|---|
| Patient characteristics | ||||
| Patient characteristics Mean age (SD), y | 61.7 (5.5) | 62.3 (5.3) | 61.2 (5.7) | .34 |
| PSA density, ng/mL/cm3a | ||||
| <0.15 | 40% (37) | 46% (20) | 35% (17) | .33 |
| ≥0.15 | 60% (55) | 55% (24) | 65% (31) | |
| MRI-fusion biopsy characteristics | ||||
| MRI of ipsilateral radiographic ROI | ||||
| Negative | 15% (14) | 11% (5) | 19% (9) | .59 |
| 3 | 24% (22) | 25% (11) | 23% (11) | |
| 4–5 | 60% (55) | 64% (28) | 57% (27) | |
| Size of ipsilateral radiographic ROI, cm | N = 40 | N = 38 | ||
| Mean (SD) | - | 1.4 (0.5) | 13 (0.6) | .20b |
| Median (IQR) | - | 1.4 (1.1–1.6) | 1.2 (0.8–1.5) | .37c |
| Anterior location of index tumord | ||||
| Yes | 48% (44) | 61% (27) | 35% (17) | .01 |
| No | 52% (48) | 39% (17) | 65% (31) | |
| Index tumor location (zone) | ||||
| Peripheral | 59% (54) | 45% (20) | 71% (34) | .04 |
| Transition | 30% (28) | 39% (17) | 23% (11) | |
| Both | 11% (10) | 16% (7) | 5% (3) | |
| Capsular involvemente | ||||
| Low risk | 69% (63) | 68% (30) | 69% (33) | .80f |
| Intermediate risk | 21% (19) | 18% (8) | 23% (11) | |
| High risk | 10% (9) | 11% (5) | 8% (4) | |
| Endorectal coil | ||||
| Yes | 11% (10) | 14% (6) | 8% (4) | .51f |
| No | 89% (82) | 86% (38) | 92% (44) | |
| Biopsy pathology: highest Gleason grade group | ||||
| 2 | 78% (72) | 77% (34) | 79% (38) | .83 |
| 3 | 22% (20) | 23% (10) | 21% (10) | |
| Biopsy type with highest Gleason grade group | ||||
| Systematic | 21% (19) | 20% (9) | 21% (10) | .41 |
| Targeted | 43% (40) | 50% (22) | 38% (18) | |
| Both | 36% (33) | 30% (13) | 42% (20) | |
| Median % positive core needle biopsy specimens (IQR) | 32% (23%−46%) | 29% (21%−41%) | 36% (26%−50%) | .06c |
| No. of pathologic foci | ||||
| Solitary | 32% (29) | 30% (13) | 33% (16) | .70 |
| Multifocal | 68% (63) | 70% (31) | 67% (32) | |
| Maximum cancer in core needle biopsy specimen, % | ||||
| <50% | 30% (28) | 32% (14) | 29% (14) | .98 |
| ≥50% | 70% (64) | 68% (30) | 71% (34) | |
| Location of CaP | ||||
| In target only | 10% (9) | 12% (5) | 8% (4) | .77f |
| Outside target only | 7% (6) | 4% (2) | 8% (4) | |
| Both | 84% (77) | 84% (37) | 83% (40) | |
| Location of csCaP | ||||
| In target only | 39% (36) | 45% (20) | 33% (16) | .48 |
| Outside target only | 16% (15) | 14% (6) | 19% (9) | |
| Both | 45% (41) | 41% (18) | 48% (23) | |
| Final whole-mount pathology characteristics | ||||
| Gleason grade group of pathologic index tumor | ||||
| 1 | 4% (4) | 0% (0) | 8% (4) | .07f |
| 2 | 74% (68) | 70% (31) | 77% (37) | |
| 3 | 15% (14) | 18% (8) | 13% (6) | |
| >3g | 7% (6) | 11% (5) | 2% (1) | |
| Median size of csCaP (IQR), cm | 2.0 (1.9–2.5) | 1.9 (1.2–2.5) | 2.0 (1.8–2.4) | .53c |
Abbreviations: CaP, prostate cancer; csCaP, clinically significant prostate cancer; IQR, interquartile range; MRI, magnetic resonance imaging; PI-RADSv2, Prostate Imaging and Data Reporting System Version 2; PSA, prostate-specific antigen; ROI, region of interest.
Based on MRI estimate of prostate size.
Derived using the Wilcoxon rank sum test.
Derived using the median test.
Target lesion if PI-RADS 3 to 5 lesion on MRI or location of biopsy with highest pathology if negative MRI.
Low risk indicates does not abut capsule, may abut capsule, or abuts <1 cm. Intermediate risk indicates abuts >1 cm, capsular bulge, and broad capsular involvement. High risk indicates macroscopic extracapsular extension, involves anterior fibromuscular stroma, and irregular.
Derived using the Fisher exact test.
Includes Gleason grade group 3 with tertiary pattern 5.