177Lu-PSMA-617 is a targeted radioligand therapy that has emerged as a promising treatment for metastatic castration-resistant prostate cancer (mCRPC). It received FDA approval on March 23, 2022, for use in patients who are PSMA-positive and have previously received androgen receptor pathway inhibition (ARPI) and taxane-based chemotherapy. Here, we present our experience.

Patients with mCRPC who had previously received ARPI, taxane-based chemotherapy, or both, and who underwent at least one cycle of ^177Lu-PSMA-617 at Taipei Veterans General Hospital between March 2023 and March 2025 were included in the study. All patients underwent PSMA PET imaging prior to treatment and had post-therapy imaging performed on the day of administration. Clinical parameters collected included age, Gleason grade group, baseline PSA doubling time, and pre-treatment PSA, ALP, and LDH levels. The primary outcome was PSA response rate. Key secondary outcomes included objective response and disease control, defined according to RECIST version 1.1. Adverse events were also evaluated.

A total of 15 patients received at least one dose of ^177Lu-PSMA-617 during the study period. Among them, 67% had prior taxane treatment, and 93% had received ARPI therapy. The median age was 71.0 years (IQR 66.5–75), and the median follow-up duration was 5.7 months (IQR 3.0–8.1). Patients received a median of 3 treatment cycles of ^177Lu-PSMA-617 (IQR 2–4). Baseline mean PSA, ALP, and LDH levels were 1327.7 ng/mL, 218.3 U/L, and 327.1 U/L, respectively. Most patients had rapidly rising PSA levels prior to treatment, with 67% exhibiting a PSA doubling time (PSADT) of less than 3 months, and 33% less than 2 months. PSA responses were observed in 33% of patients, with 60% of these achieving PSA reductions of up to 90%. The objective response rate (ORR) was 31%. Grade 3 adverse events occurred in 46.6% of patients.

Our experiences provided the real-world outcome of 177Lu-PSMA-617 in a Taiwanese population previously treated with taxanes and ARPIs. Despite having more advanced baseline conditions, PSA and objective response rates were comparable to those reported in the VISION and TheraP trials.