A new cohort study analysing individual patient data from 2,187 men enrolled in the SPARTAN and TITAN trials has found that statin exposure is associated with superior overall survival in patients with advanced prostate cancer treated with apalutamide. This finding emphasises the potential beneficial role of statins when combined with androgen deprivation therapy (ADT) and apalutamide, particularly in metastatic hormone-sensitive and nonmetastatic castration-resistant prostate cancer.
Survival Benefits and Cardiac Risks of Statins
The analysis revealed that men receiving statins alongside apalutamide had significantly higher three-year survival rates compared with those not exposed to statins, with survival differences of 14% and 8% in the TITAN and SPARTAN trials, respectively. However, statin use was also linked to an increased risk of grade 3 or higher cardiac adverse events, likely reflecting the preexisting cardiovascular comorbidities common in this patient group.
These findings highlight the dual considerations clinicians must weigh when prescribing statins for men with advanced prostate cancer undergoing apalutamide treatment. While statins may improve overall survival, vigilant cardiac monitoring is warranted to manage potential adverse cardiac events.
Statin Exposure and Overall Survival
The cohort study utilised individual data from two multicentre phase 3 randomised clinical trials. The TITAN trial focused on metastatic hormone-sensitive prostate cancer, while SPARTAN involved patients with nonmetastatic castration-resistant prostate cancer. Both trials randomised patients to receive ADT with or without apalutamide. Statin exposure, which could start before or during the assigned treatment, was analysed for associations with overall survival and cardiac adverse events.
In both trials, apalutamide-treated patients with statin exposure demonstrated superior overall survival compared to those without statins. Notably, the improvement was not observed in placebo groups. The increased cardiac event risk in statin users underscores the importance of cardiovascular assessment before and during therapy.
Clinical Implications and Future Perspectives
These results suggest a possible complementary role for statins in improving outcomes for men receiving advanced prostate cancer therapies, but also emphasise the need for careful cardiovascular risk management. Future clinical practice should incorporate routine cardiac monitoring and risk mitigation strategies when prescribing these agents concurrently.
Reference
Roy S et al. Statin use in patients with advanced prostate cancer in the TITAN and SPARTAN trials. JAMA Netw Open. 2025;8(8):e2527988.