Table 4.
Post-treatment MRI Characteristics and PSA levels (efficacy population)
| Studies | All studies | |||
|---|---|---|---|---|
| PCM201 | PCM202 | PCM203 | ||
| N = 35 | N = 21 | N = 61 | N = 117 | |
| Day 7 prostate MRI results, mean (SD) | ||||
| Prostate volume by planimetry (mL) | 62.7 (24.2) | 56.7 (23.4) | 58.9 (18.4) | 59.6 (21.1) |
| Volume of necrosis by planimetry (mL) | 19.5 (8.9) | 18.4 (10.9) | 26.0 (13.5) | 23.0 (12.5) |
| Percentage necrosis (%) | 68.8 (34.5) | 64.1 (25.3) | 83.8 (20.9) | 76.5 (26.6) |
| PSA levels (ng/mL), mean (SD) | ||||
| Baseline | 5.6 (2.1) | 3.7 (2.4) | 6.2 (2.4) | 5.6 (2.5) |
| At 1 month | 4.5 (3.1) | 4.7 (4.0) | 4.9 (3.8) | 4.8 (3.6) |
| Change from baseline at 1 month | −1.1 (3.6) | 0.9 (3.1) | −1.2 (4.2) | −0.8 (3.9) |
| At 3 months | 3.1 (1.8) | 3.5 (3.4) | 3.6 (2.2) | 3.4 (2.3) |
| Change from baseline at 3 months | −2.6 (2.4) | −0.1 (2.6) | −2.5 (2.4) | −2.1 (2.6) |
| At 6 months | 3.5 (3.2) | 2.9 (2.2) | 3.8 (2.5) | 3.5 (2.7) |
| Change from baseline at 6 months | −2.1 (3.4) | −0.8 (1.0) | −2.4 (2.4) | −2.0 (2.7) |