Prostate cancer is the most diagnosed cancer in men worldwide, but little is known about why some cancers are slow-growing, with patients remaining symptom-free, and why some cancers become aggressive.
This uncertainty complicates research and clinical decision-making. Standard screening tests cannot reliably tell the difference between slow-growing, harmless tumours and fast-spreading, dangerous ones, for which effective pharmaceutical intervention to reduce tumour growth and increase survival is required.
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During the first Presidential Symposium at the European Society of Medical Oncology (ESMO) congress 2026, taking place in Madrid, Spain, from 23 to 27 October, data from the DASL-HiCaP study, which enrolled 1,106 patients, was presented, showing a four-year metastasis-free survival based on conventional imaging (MFS-CI) rate of 95%, compared to 88% in the comparator arm.
The study pitted darolutamide, radiotherapy and androgen deprivation therapy (ADT) against radiotherapy plus ADT in patients with very high-risk localised prostate cancer.
At a median follow-up of 3.8 years, the interim analysis demonstrated a 58% reduction in the risk of metastasis or death with Bayer’s Nubeqa (darolutamide) plus ADT and radiotherapy compared with placebo plus ADT and radiotherapy.
There were also improvements in secondary endpoints such as prostate-specific antigen progression-free survival (HR 0.47; 95% CI 0.33–0.67) and time to subsequent hormonal therapy (HR 0.36; 95% CI 0.22–0.59).
Speaking at ESMO to Clinical Trials Arena, Frank Verholen, global medical and evidence lead for Nubeqa at Bayer, said: “MFS-CI is the only so far known surrogate for overall survival, meaning that if this data were positive, it will likely translate into an overall survival benefit.”
Nubeqa is being investigated in other prostate cancer trials, including the ARASTEP trial (NCT05794906), which is looking at the drug’s potential in patients with high-risk biochemical recurrence (BCR) of prostate cancer who have at least one positive lesion detected on advanced PSMA PET/CT scans.
Previous studies, including the AREMA study, investigated the therapy in patients with castrate-resistant prostate cancer, and the ARASENTS and ARANODE studies in metastatic hormone-sensitive prostate cancer. These studies led to approval of the drug in the US, EU, UK, China, Canada and Australia.
Long-term survival benefit with abiraterone combinations
Adding abiraterone to standard treatment provides a lasting survival benefit for men whose prostate cancer has already spread at diagnosis, reinforcing the value of early treatment intensification.
Data from the STAMPEDE study (NCT00268476) showed that treatment with abiraterone and prednisolone to radiotherapy plus ADT significantly improved both MFS and OS, also in a very high-risk population.
Conversely, in the ENZARAD study (NCT02446444), which added enzalutamide to radiotherapy plus ADT in a high-risk population with lower risk, there was no significant effect on MFS, although benefits were reported in subgroups of patients with positive pelvic nodes or with pelvic radiotherapy planned.
Other data that come from almost eight years of follow-up in the academically led Phase III PEACE-1 trial (NCT01957436) found that for men with de novo metastatic castration-sensitive prostate cancer, the risk of death was reduced by 25% when adding abiraterone to standard of care (SOC). Median OS was 6.1 years with abiraterone versus 4.6 years without it.
The PEACE-1 trial included 1,173 patients who all received SOC of an ADT, with or without docetaxel chemotherapy. They were then randomly assigned to receive no additional treatment, abiraterone plus prednisone, radiotherapy to the prostate, or both abiraterone plus prednisone and radiotherapy.
Overall, 57% had high-volume disease, indicating more extensive cancer spread. An earlier analysis showed that adding abiraterone to standard of care improved overall survival.
Among the 710 men who received ADT plus docetaxel, adding abiraterone plus prednisone reduced the risk of death by 32%.
In men with high-volume disease, median survival was 4.6 years with triplet therapy versus 3.5 years with doublet therapy, and almost twice as many were alive at eight years (38% vs 20%).
In men with low-volume disease, median survival was 7.8 years with triplet therapy versus 6.2 years with doublet therapy, although this difference was not statistically significant on its own.
“There is a major survival benefit, with almost two years of additional life for patients receiving the three treatments, which is of course highly significant,” said lead author Dr Karim Fizazi, Centre Oscar Lambret, Lille, France.
“In our opinion, this makes this triplet treatment a strong SoC for these patients. Most clinical trials, especially when led by pharma companies, tend to stop their follow-up early. This long-term analysis demonstrated that the survival benefit becomes greater with time: for instance, in men with multiple metastases at diagnosis, there are almost twice as many long-term survivors with triplet therapy.”
Syncromune’s prostate cancer vaccine shows promise
Another notable prostate cancer readout was for Syncromune’s Phase I trial (NCT05544227) of its SYNC-T Therapy SV-102, an in situ personalised cancer vaccine. The drug acts by freezing a portion of a tumour to release personalised antigens, then injecting a fixed-dose drug cocktail directly into the site to prime a systemic anti-tumour immune response.
Data showed an 87% ORR and a 40% complete response rate (CRR) in patients with metastatic castration-resistant prostate cancer (mCRPC).
Dr Charles Link, executive chairman and chief innovation officer, told Clinical Trials Arena that of the six patients who had confirmed CRR in the study, as they approach the three-year mark, they continue to have no disease recurrence.
Syncromune has now started recruiting in a Phase IIa study (NCT06533644) which is aiming to enrol 36 patients.
