The results of two new studies were announced on the third day of EAU19: the eagerly awaited and possibly paradigm-changing ARAMIS study and new research into fast bi-parametric MRI. Delegates braved the early hours of Sunday morning to attend the Breaking News Session that was part of Plenary Session 3, on imaging in PCa.
Prof. Teuvo Tammela (FI) presented the latest results of the ARAMIS study, which tested the effects of darolutamide on the PSA levels of men with non-metastatic castration-resistant prostate cancer (nmCRPC). “The latest results indicate that darolutamide significantly improves metastasis-free survival in men with nmCRPC. It elicits strong PSA declines and significantly delays PSA progression compared to placebo. Because it also has a favourable safety profile, we think darolutamide could be an attractive option for treating nmCRPC.”
Prof. Peter Albers (DE) was on hand to place these findings in a wider context, first pointing out that the selection criteria were limited to patients with very short and aggressive doubling times. He also explained that due to its differing chemical structure, darolutamide led to fewer side-effects compared to enzalutamide and apalutamide.
Albers: “The overall survival curves separate after about 18 months, so we have to wait longer. The study has a surrogate endpoint of metastatic-free survival.”
“Darolutamide is a new and effective next-generation androgen receptor inhibitor,” Albers concluded. It has a better safety profile compared to enzalutamide and apalutamide, and will change practice if the advantage in metastasis-free survival leads to an overall survival advantage. It does however need strong selection criteria to prevent overtreatment.”
Prof. Jelle Barentsz (NL) presented the latest results from a multi-centre study on 626 biopsy-naïve patients, hoping to convince the audience that a “fast” prostate MRI without contrast is cheap, non-invasive and can double prostate MRI capacity.
The study compared contrast-enhanced multi-parametric full MRI protocol (mpMRI, 16 minutes) to an unenhanced, bi-parametric MRI (bpMRI, 13 minutes) and a fast bpMRI protocol (8 minutes). The latest data showed that non-invasive fast bpMRI without contrast agent can accurately detect and rule-out csPCa. Additionally, bpMRI-fast can be performed at significantly lower (55%) costs. In addition, the potential side-effects of Gd-injection (e.g. Gd-brain deposition, allergic reaction) are reduced to zero. The full results will be published soon in European Urology.
Prof. Briganti (IT) pointed out that the results depend largely on the availability of the highest quality MRI and most experienced radiologists, warning that fast bpMRI is possibly ready to replace mpMRI in all patients, but only at selected centres.