Efficacy and Safety of 177Lu-PSMA-617 in Combination with Radical Prostatectomy and Bilateral Orchiectomy in Men with Castrate-Sensitive Metastatic Prostate Cancer: A Pilot Study.

Abstract

To investigate the efficacy and safety of 177Lu-PSMA-617 in combination with radical prostatectomy and bilateral orchiectomy in adult male patients with castrate-sensitive metastatic prostate cancer. This pilot study included 12 men with metastatic prostate cancer who underwent radical prostatectomy and received 177Lu-PSMA-617 in combination with hormonal therapy. The primary endpoint was the proportion of patients who achieved a PSA response, defined as a ≥50% reduction in PSA levels at first follow up from baseline. Secondary endpoints were the proportion of patients who achieved a PSA response, defined as a ≥50% reduction in PSA levels at second follow up from first one and progression in pain severity that was defined as an increase in score of 30% or greater from baseline without decrease in analgesic use based on Brief Pain Inventory-short Form (PBI-SF). The PSA levels of 9(75.0%) patients are reduced after first course of 177Lu-PSMA-617, additional reduction was observed in 7(58.3%) patients after receiving the 2nd course of treatment. Of the 12 patients, 3(25.0%) achieved a PSA response (≥50% reduction in PSA levels) at first follow up visit and 3(25.0%) patients had PSA response at second follow up, 6 patients (50.%) had a pain response. The most common adverse events were Mouth dryness and fatigue, which were manageable with supportive care. This pilot study suggests that radical prostatectomy and hormonal therapy in combination with 177Lu-PSMA-617 is a safe and effective treatment option and may have a role in the management of select patients with castrate-sensitive metastatic prostate cancer. Further studies are needed to confirm these findings and determine the optimal use in this setting.