Table 1.
New hormone therapies currently approved by EMA in the different settings of PCA
| Drug | Setting | Phase III trial | Year of EMA approval |
| M0 disease | |||
| Enza | CRPC at high risk of metastases* | PROSPER48 | 2018 |
| Apa | CRPC at high risk of metastases* | SPARTAN49 | 2019 |
| M1 disease | |||
| AAP | Post-CT CRPC | COU-AA-30199 | 2011 |
| AAP | CT-naive CRPC | COU-AA-30267 | 2012 |
| AAP | Newly diagnosed high-risk HSPC | LATITUDE57 58 | 2017 |
| Enza | Post-CT CRPC | AFFIRM59 | 2012 |
| Enza | CT-naive CRPC | PREVAIL60 | 2014 |
*Baseline PSA level of 2 ng per millilitre or greater, and a PSA doubling time of 10 months or less.
AAP, abiraterone acetate plus prednisone; Apa, apalutamide; CRPC, castration-resistant prostate cancer; CT, chemotherapy; EMA, European Medicines Agency; Enza, enzalutamide; HSPC, hormone-sensitive prostate cancer; M0, non-metastatic; M1, metastatic; PSA, prostate-specific antigen.