Table 2.
Sensitivity analyses of non-inferiority for PSA outcomes.
| Visit | Marker | Analysis | Microsphere | CI (microsphere) | Implant | CI (implant) | Difference |
|---|---|---|---|---|---|---|---|
| D29 | TPSA | Main (TPSA < 0.2) | 36/44 (81.8%) | 67.3%, 91.8% | 40/42 (95.2%) | 83.8%, 99.4% | -0.134 |
| D85 | TPSA | Main (TPSA < 0.2) | 38/44 (86.4%) | 72.6%, 94.8% | 40/43 (93.0%) | 80.9%, 98.5% | -0.067 |
| D29 | TPSA | Sensitivity (TPSA < 0.1) | 34/44 (77.3%) | 62.2%, 88.5% | 40/42 (95.2%) | 83.8%, 99.4% | -0.18 |
| D85 | TPSA | Sensitivity (TPSA < 0.1) | 37/44 (84.1%) | 69.9%, 93.4% | 40/43 (93.0%) | 80.9%, 98.5% | -0.089 |
| D29 | FPSA | Main (FPSA < 0.01) | 30/37 (81.1%) | 64.8%, 92.0% | 34/35 (97.1%) | 85.1%, 99.9% | -0.161 |
| D85 | FPSA | Main (FPSA < 0.01) | 31/35 (88.6%) | 73.3%, 96.8% | 34/36 (94.4%) | 81.3%, 99.3% | -0.059 |
| D29 | FPSA | Sensitivity (FPSA < 0.005) | 0/37 (0.0%) | 0.0%, 9.5% | 0/35 (0.0%) | 0.0%, 10.0% | 0 |
| D85 | FPSA | Sensitivity (FPSA < 0.005) | 0/35 (0.0%) | 0.0%, 10.0% | 0/36 (0.0%) | 0.0%, 9.7% | 0 |
CI, confidence interval; D, day; FPSA, free prostate-specific antigen; TPSA, total prostate-specific antigen. Data are presented as n/N (%), where n represents the number of responders and N represents the total number of evaluable patients. “Main” indicates the primary analysis using predefined thresholds, whereas “Sensitivity” indicates sensitivity analyses using more stringent thresholds or alternative handling of values below the limit of detection. The Clopper–Pearson method was used to calculate 95% confidence intervals. Difference refers to the response rate difference between the Microsphere group and the Implant group (Microsphere minus Implant).