Table 5.
Post-treatment MRI characteristics and PSA levels (PP population with LDI ≥ 1)
| Studies | All studies | |||
|---|---|---|---|---|
| PCM201 | PCM202 | PCM203 | ||
| N = 12 | N = 15 | N = 49 | N = 76 | |
| Biopsy results at month 6 | ||||
| Negative biopsy, n (%) | 10 (83.3) | 11 (73.3) | 38 (77.6) | 59 (77.6) |
| Exact 95 % CI | (51.6, 97.9) | (44.9, 92.2) | (63.4, 88.2) | (66.6, 86.4) |
| Day 7 MRI results, Mean (SD) | ||||
| Prostate volume by planimetry (mL) | 46.9 (9.3) | 62.3 (19.4) | 56.0 (18.6) | 55.8 (18.0) |
| Volume of necrosis by planimetry (mL) | 17.9 (4.5) | 21.5 (8.1) | 24.3 (11.4) | 23.0 (10.4) |
| Percentage necrosis (%) | 96.4 (25.0) | 74.3 (15.3) | 88.5 (18.6) | 86.3 (19.6) |
| PSA (ng/mL) results, mean (SD) | ||||
| Baseline | 5.8 (2.8) | 4.0 (2.1) | 6.1 (2.5) | 5.6 (2.6) |
| At 1 month | 3.3 (3.2) | 5.5 (4.4) | 4.6 (2.9) | 4.5 (3.3) |
| Change from baseline at 1 month | −2.4 (3.6) | 1.3 (3.6) | −1.5 (3.3) | −1.1 (3.6) |
| At 3 months | 2.6 (2.5) | 3.8 (3.6) | 3.4 (1.9) | 3.3 (2.4) |
| Change from baseline at 3 months | −3.2 (3.4) | −0.1 (3.0) | −2.7 (2.2) | −2.3 (2.8) |
| At 6 months | 1.9 (1.7) | 2.8 (1.8) | 3.8 (2.6) | 3.3 (2.4) |
| Change from baseline at 6 months | −3.8 (2.7) | −1.2 (0.9) | −2.3 (2.4) | −2.3 (2.4) |