Table 3.
Prostate biopsy results at month 6: overall and by LDI and laterality
| All studies | By study | By LDI and laterality | ||||||
|---|---|---|---|---|---|---|---|---|
| PCM201 | PCM202 | PCM203 | LDI < 1 | LDI ≥ 1 | ||||
| 4 mg/kg 200 J/cm | 4 mg/kg 200 J/cm | 4 mg/kg 200 J/cm | 4 mg/kg 200 J/cm | |||||
| Unilateral | Bilateral | Unilateral | Bilateral | |||||
| N = 117 | N = 35 | N = 21 | N = 61 | N = 20 | N = 18 | N = 68 | N = 11 | |
| Prostate biopsy at month 6 | 114 | 34 | 21 | 59 | 19 | 17 | 67 | 11 |
| Number (%) patients | ||||||||
| Positive biopsy | 36 (31.6) | 16 (47.1) | 8 (38.1) | 12 (20.3) | 11 (57.9) | 8 (47.1) | 13 (19.4) | 4 (36.4) |
| Negative biopsy | 78 (68.4) | 18 (52.9) | 13 (61.9) | 47 (79.7) | 8 (42.1) | 9 (52.9) | 54 (80.6) | 7 (63.6) |
| Exact 95 % CIa | (59.1, 76.8) | (35.1, 70.2) | (38.4, 81.9) | (67.2, 89.0) | (20.3, 66.5) | (27.8, 77.0) | (69.1, 89.2) | (30.8, 89.1) |
If a patient discontinued the study prior to month 6 but more than 3 months following day 1, a biopsy was performed at the time of patient discontinuation. These biopsy results were included with the others
aFor the percentage of patients with negative biopsy assessment