Table 3.
The number and percent of CAMUS participants categorized by baseline PSA levels and by treatment arm with rises in PSA over the study period.
| Saw Palmetto | Placebo | ||
|---|---|---|---|
| Baseline PSA (ng/ml) | % (n/N) with any PSA rise for entire study period | % (n/N) with any PSA rise for entire study period | p value |
| 0≤PSA<2.5 | 83.3 (110/132) | 91.2 (125/137) | 0.07* |
| 2.5≤PSA<4 | 92.6 (25/27) | 96.0 (24/25) | 1.00* |
| 4≤PSA≤10 | 95.8 (23/24) | 82.6 (19/23) | 0.19* |
| Baseline PSA (ng/ml) | Median of PSA rise for entire study period | Median of PSA rise for entire study period | |
| 0≤PSA<2.5 | 0.135 | 0.08 | |
| 2.5≤PSA<4 | -0.08 | -0.09 | |
| 4≤PSA≤10 | 0.66 | 0.09 | |
| Baseline PSA (ng/ml) | %(n/N) with annualized PSA rise for any PSA testing interval that exceeded the relevant NCCN cutpoints† | %(n/N) with annualized PSA rise for any PSA testing interval that exceeded the relevant NCCN cutpoints† | p value |
| 0≤PSA<2.5 | 56.8 (75/132) | 55.5 (76/137) | 0.90* |
| 2.5≤PSA<4 | 81.5 (22/27) | 88.0 (22/25) | 0.71* |
| 4≤PSA≤10 | 95.8 (23/24) | 73.9 (17/23) | 0.05* |
| Baseline PSA (ng/ml) | % (n/N) with annualized PSA rise exceeding the relevant NCCN cutpoints† during the 48-72 week time period | % (n/N) with annualized PSA rise exceeding the relevant NCCN cutpoints† during the 48-72 week time period | p value |
| 0≤PSA<2.5 | 32.2 (37/132) | 26.0 (32/137) | 0.32* |
| 2.5≤PSA<4 | 53.9 (14/25) | 52.0 (13/25) | 1.00* |
| 4≤PSA≤10 | 81.0 (17/24) | 55.0 (11/23) | 0.10* |
*
P values are for comparison of saw palmetto and placebo groups and are based on Fisher's exact test (twosided).
†
For men with a PSA <4 ng/ml, a PSA velocity ≥0.35 ng/ml/year is suspicious for cancer. For men with a PSA of 4-10 ng/ml, a PSA velocity ≥0.75 ng/ml/year is suspicious for cancer.