I’m Natalia Gandur from Argentina, I’m here in Berlin at the ESMO 2025 Congress where the advances in prostate cancer were truly remarkable. This year we saw data that redefined both the management of metastatic hormone sensitive disease and high risk localised prostate cancer.
Let’s start with PSMAddition presented by Dr Scott Tagawa from the Presidential Symposium. This is the first phase III trial to evaluate PSMA-targeted radioligand therapy in the hormone-sensitive metastatic setting. This study compared ADT plus ER pathway inhibitor, ARPIs, with or without the addition of lutetium-PSMA, a beta-emitting radioligand that delivers targeted radiation directly to PSMA-expressing tumour cells. More than [1,100] patients with PSMA positive disease were randomised. In the interim analysis presented here in Berlin, the addition of lutetium significantly improved radiographic progression free survival with a hazard ratio of 0.72, a consistent benefit across all subgroups, including both high and low volume disease.
Another important fact is that overall survival data are not yet mature but there is already a favourable trend we show. Tumour response and PSA progression also improve with an overall response rate above 85% and the treatment was well tolerated with mild fatigue, dry mouth and grade 3-4 cytopenias in around 40% of patients. Quality of life, remarkably, was stable, this is very good, very important data. Dr Tagawa stated that this is the first trial showing that adding PSMA-targeted therapy or radioligands to intensified hormonal therapy improves disease control in patients metastatic sensitive. Now, this is very important data because this scenario is not the most easy to manage.
Next we heard from Dr Paul Nguyen from Dana-Farber Cancer Institute the study called ENZARAD trial during one of the most important sessions. This phase III academic international study compared ADT plus radiotherapy with or without enzalutamide in high-risk or locally advanced localised prostate cancer. After eight years, a very long follow-up, the trial did not show a significant improvement in metastatic free survival in the overall population. However, if we see the subgroup analysis we can find that patients with nodal involvement and patients who receive pelvic field radiotherapy, these patients had a clear benefit. No significant difference in overall survival was observed but PSA progression free survival improved. Toxicities were manageable with slightly more fatigue, hypertension and [??] in the enzalutamide arm.
Finally, Dr Peter Godolphin presented the STOPCAP meta-analysis which assessed the role of prostate radiotherapy in men with de novo metastatic hormone-sensitive disease. This analysis included data from 2,000 patients from STAMPEDE, PEACE-1 and HORRAD. Results showed that radiotherapy to the primary tumour provided significant improvement in progression free survival with the benefit limited, this is the important thing, to patients with low-volume disease, those with fewer than five bone metastases, showing an 8% absolute improvement in 5-year survival. This confirms that treating the prostate primary tumour can indeed improve outcomes in low-volume metastatic disease.
In summary, ESMO 2025 was a milestone for prostate cancer with three clear messages. The first, PSMAddition established PSMA radioligands as a new standard in metastatic hormone-sensitive patients. ENZARAD redefines hormonal intensification, showing benefit in specific subgroups, and STOPCAP confirms the benefit of prostate radiotherapy in low-volume metastatic disease.
From Berlin, I’m Natalia Gandur and I hope this data will be useful for you and these key highlights in prostate cancer were very impressive, really. Thank yo
