What You Should Know About the Latest Lu-177-PSMA Advances

In August 2022, Koo Foundation Sun Yat-Sen Cancer Center performed Taiwan’s first Lutetium-177 PSMA (Lu-177-PSMA) therapy. We are now approaching the three-year mark. Even earlier, beginning in 2019, our team helped refer prostate cancer patients to Singapore for Lu-177-PSMA treatment, making us the earliest hospital in Taiwan to focus on and deliver this important option. To date, we have the country’s most extensive clinical experience with this therapy.

Lu-177-PSMA combines the precision of targeted drugs with the power of radionuclide therapy. Its benefits and side-effect profile differ from traditional approaches, and success depends on close collaboration among nuclear medicine, medical oncology, urology, and other specialties. Along the way we have cared for many patients with severe, complex disease and even set a global precedent by treating people on dialysis, building a valuable body of real-world evidence.

Across these three years our patients initially tended to be very ill, which made care intensely complex. Every step required heightened vigilance, tight monitoring, and timely adjustments. By the second and third years, we had refined the timing of therapy and gained strong confidence in its effects, while developing practical strategies to prevent and manage side effects. Take the most frequently mentioned concern, salivary-gland dysfunction that leads to dry mouth. Thanks to careful preventive measures and meticulous attention to clinical details, none of our patients receiving Lu-177-PSMA at KFSYSCC has experienced this side effect.

Another common issue is bone-marrow suppression. Through in-house clinical analysis supported by artificial-intelligence tools, we identified the key predictors of serious marrow toxicity and tailored treatment plans accordingly. As a result, significant marrow side effects have become rare. Careful on-treatment assessment is equally important. Because this therapy is not yet covered by Taiwan’s National Health Insurance and is costly, we judge efficacy especially carefully. We interpret lab and imaging indicators, decide whether to adjust the plan, consider possible combinations, and determine whether to pause or continue therapy. With our mature clinical experience, we provide patients with sound guidance before and throughout treatment.

Recent developments continue to broaden access. First, the Lu-177-PSMA drug—marketed in Taiwan as Pluvicto—has received full marketing authorization. This means physicians across the country can now offer the treatment without special access procedures.

Second, large studies have confirmed that Lu-177-PSMA-617 benefits patients who have not yet had chemotherapy, and many countries in Europe and the United States have approved this use. The global randomized trial known as PSMAfore enrolled men with metastatic castration-resistant prostate cancer who had become resistant to hormonal castration and had already received one androgen-receptor pathway inhibitor (ARPI), such as enzalutamide or abiraterone, without success. An interim analysis released in 2023 showed that, compared with switching to another ARPI, Lu-177-PSMA-617 significantly prolonged radiographic progression-free survival (rPFS), with a hazard ratio of 0.49, a difference that was statistically meaningful.

In addition, the manufacturer announced on its official website this March that adjusted analyses demonstrated a significant overall-survival advantage. The hazard ratio was 0.51, indicating a 49 percent reduction in the risk of death for this patient group. Based on these results, the U.S. FDA has approved Lu-177-PSMA-617 for use before chemotherapy, further expanding its clinical role.

A third important update is expected soon. It concerns first-line treatment for patients who present with de novo metastatic, castration-sensitive prostate cancer. Stay tuned for details once the formal results are released.

To help patients prepare, we will also explain what to expect during the Lu-177-PSMA infusion process in an upcoming piece.