Table 2:
Baseline demographics and clinical characteristics
| All enrolled subjects N=35 | Cohort 1: Whole prostate [V1/V2pre/V2post all analyzable] N=29 | Cohort 2: Focal lesion [V1/V2pre/V2post all analyzable] N=10 | ||||
|---|---|---|---|---|---|---|
|  | ||||||
| N | % | N | % | N | % | |
| Age | ||||||
| Mean (SD) | 64.5 (7.3) | 64.4 (7.1) | 62.0 (6.7) | |||
| Median (Range) | 63 (52,80) | 63 (53, 80) | 60.5 (53, 78) | |||
|  | ||||||
| Race | ||||||
| Black/African American | 3 | 9% | 3 | 10% | 0 | 0% | 
| White | 29 | 83% | 23 | 79% | 9 | 90% | 
| Not reported/Unknown | 3 | 9% | 3 | 10% | 1 | 10% | 
|  | ||||||
| Ethnicity | ||||||
| Hispanic/Latino | 3 | 9% | 3 | 10% | 0 | 0% | 
| Not Hispanic/Latino | 31 | 89% | 25 | 86% | 10 | 100% | 
| Not reported/Unknown | 1 | 3% | 1 | 3% | 0 | 0% | 
|  | ||||||
| Insurance Status | ||||||
| Private insurance | 22 | 63% | 19 | 66% | 9 | 90% | 
| Medicare/Other government insurance | 7 | 20% | 6 | 21% | 0 | 0% | 
| Medicaid/Uninsured | 6 | 17% | 4 | 14% | 1 | 10% | 
|  | ||||||
| PSA (ng/mL) | ||||||
| Mean (SD) | 14.7 (25.8) | 10.6 (9.7) | 12.2 (15.4) | |||
| Median (Range) | 8.4 (3.7, 153.5) | 8.4 (3.7, 55.2) | 7.3 (4.1, 55.2) | |||
|  | ||||||
| Gleason Score | ||||||
| Unknown | 1 | 3% | 0 | 0% | 0 | 0% | 
| 6 | 3 | 9% | 3 | 10% | 1 | 10% | 
| 7 | 26 | 74% | 23 | 79% | 7 | 70% | 
| 8 | 2 | 6% | 2 | 7% | 2 | 20% | 
| 9 | 3 | 9% | 1 | 3% | 0 | 0% | 
|  | ||||||
| Core Biopsy Tumor Density a | ||||||
| Low | 13 | 37% | 9 | 31% | 2 | 20% | 
| High | 22 | 63% | 20 | 69% | 8 | 80% | 
High density: one core ≥ 50% tumor burden and ≥ 5mm in tumor length, two or more cores ≥ 30% tumor burden, or three or more positives cores in the same sextant.