Table 3.
PSA Changes, Prostate Nodules, Prostate Biopsies, and Prostate Cancers Diagnosed During and 6 Mo After Stopping Testosterone Treatment
| Event | Month 3 | Month 12 | Month 18 | |||
|---|---|---|---|---|---|---|
| Testosterone | Placebo | Testosterone | Placebo | Testosterone | Placebo | |
| N | 371 | 373 | 362 | 343 | 335 | 318 |
| Confirmed PSA increase >1.0 (ng/mL)a | 6/371 (1.6%) | 4/372 (1.1%) | 13/361 (3.6%) | 5/343 (1.5%) | 5/335 (1.5%) | 5/318 (1.6%) |
| PSA >4.0 (ng/mL) | 8/371 (2.2%) | 6/373 (1.6%) | 16/362 (4.4%) | 6/343 (1.7%) | 8/335 (2.4%) | 13/318 (4.1%) |
| Prostate nodule but no PSA increase | 0 | 0 | 0 | 0 | 0 | 1 |
| Prostate biopsies | 1 | 0 | 1 | 1 | 2 | 1 |
| Prostate cancer | 1 | 0 | 0 | 0 | 2 | 1 |
a
PSA values were adjusted for low testosterone at months 3 and 12 (during testosterone treatment) but not month 18 (6 months after completion of treatment).