Table 2.
Summary of current nonradical treatment trials for localized PCa
| Study | Study type | Men randomized (N) | Cohort pathology | Intervention | Primary outcome | Result for treatment arm |
|---|---|---|---|---|---|---|
| ENACT 2022 | RCT | 227 | Low risk Intermediate risk |
Enzalutamide vs. AS | 1. Time to PCa progression | 1. HR 0.54; 95% CI (0.33-0.89) P = 0.02∗ |
| EPC Programme 2006 | RCT | 8113 | Low risk Intermediate risk |
Bicalutamide + AS vs. Placebo + AS vs. AS alone | 1. Progression free survival 2. Overall survival |
1. HR 1.16; 95% CI (0.99 – 1.37); P = 0.07 2. HR 0.65; 95% CI (0.44-0.95); P = 0.03∗ |
| REDEEM 2010 | RCT | 302 | Low risk | Dutasteride vs. placebo | 1. Time to PCa progression | 1. HR 0.62; 95% CI (0.43 – 0.89); P = 0.009∗ |
| PCM301 2018 | RCT | 413 | Low risk | Focal photodynamic therapy vs. AS | 1. Conversion to radical intervention at 4 years 2. Overall cancer progression |
1. HR 0.31, 95% CI (0.21-0.46); P < 0.05∗ 2. HR 0.42, 95% CI (0.29-0.59); P < 0.05∗ |
| Jarrard et al 2021 | RCT | 30 | Low risk | Pomegranate vs. AS | 1. Altered serum prostate tissue biomarkers 2. Number of positive cores on biopsy |
1. Urothelin A P=<0.01∗ DMEAG P=<0.001∗ 2. Positive core biopsy P = 0.06 |
| PROSTVAC 2018 | RCT | 1297 | Low risk | Immunotherapy vs. AS | 1. Change in CD8+ and CD4+ expression | Results not published |
| ERASE 2019 | RCT | 52 | Low risk | Exercise vs. AS | 1. Cardiorespiratory fitness 2. Immunosurveillance of cancer related biomarkers |
Results to be finalized |
Low risk: cT1c-T2a, PSA <10 ng/mL. Nx/0 M0 and GS 6.
Intermediate risk: cT2B-T2c, PSA <20 ng/mL. N0 M0, and GS 7 (3 + 4 pattern only).
∗
Significant result demonstrating treatment benefit.