Real-world data confirm that 177Lutetium PSMA-617 (177Lu PSMA) is effective for treating metastatic castration-resistant prostate cancer (mCRPC), according to a recent study.

A PSA decrease of 30% or greater after the first 2 cycles of the radioligand therapy “is an early marker of response that can be easily implemented in clinical practice,” Isabel Heidegger, MD, of Medical University Innsbruck in Austria and colleagues reported in European Urology Oncology.

 The investigators retrospectively studied 233 patients with mCRPC who received 177Lu PSMA at 8 high-volume European centers. They observed a 30% or greater decrease in PSA in 41.7%, 63.5%, and 77.8% of patients after the first, second, and third treatment cycle, respectively. Restaging using PSMA positron emission tomography-computed tomography demonstrated that 33.7% of patients had an imaging-based response, including 2 patients with a complete response. Another 13.4% had stable disease. Patients with any PSA rise after the first cycle of 177Lu PSMA had a significant 2.1-fold higher risk for disease progression, Dr Heidegger and colleagues reported.

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The median time to progression was 5 months compared with 8.7 months in the phase 3 randomized multicenter VISION trial. Dr Heidegger and colleagues wrote that “the reason for the difference might be that our cohort included heavily pretreated patients and patients with ECOG performance status of 2 or 3.” In addition, more than 80% of patients in their study had grade group 4 or 5 cancer at primary diagnosis, “reflecting the aggressive disease phenotype in our cohort.”

The median time until initiation of a consecutive anti-neoplastic treatment was 8.5 months.

A PSA decrease of 30% or more after the first 2 cycles of 177Lu PSMA, absolute PSA after the first 3 cycles, and PSA doubling time greater than 6 months correlated significantly with treatment response, according to the investigators.

By the end of the study, 48% of patients were alive, 48% had died from prostate cancer, and 4% had died from other causes.

Among patients without visceral metastases, a gamma-glutamyl transferase level of 31 U/L or less at the start of 177Lu PSMA therapy was significantly correlated with a 1.5 times higher risk of progression in patients.


Kafka M, Horninger A, di Santo G, et al. Real-world outcomes and predictive biomarkers for 177Lutetium prostate-specific membrane antigen ligand treatment in metastatic castration-resistant prostate cancer: A European Association of Urology Young Academic Urologists Prostate Cancer Working Group Multi-institutional Observational Study. Eur Urol Oncol. Published online August 19, 2023. doi:10.1016/j.euo.2023.07.018