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DOI: 10.1055/s-0040-1708448
Lutetium-177-PSMA-617 in low-volume hormone sensitive metastatic prostate cancer: a prospective study
Publication History
Publication Date:
08 April 2020 (online)
Ziel/Aim ± 30 % of prostate cancer (PC) patients present with disease recurrence after radical surgery or radiotherapy. Lutetium-177-PSMA-617 (Lu-PSMA) is a promising treatment for castration-resistant PC. Based on the mode of action, patients in the hormone sensitive (HS) stage could potentially benefit too. We aimed to investigate the tolerability, dosimetry, and treatment response of Lu-PSMA in these early stage patients who presented with disease recurrence and had high expression on PSMA-PET.
Methodik/Methods In this ongoing prospective study (NCT03828838), 10 patients with low-volume (< 10 lesions) HS PC and PSA doubling time < 6 months will receive two cycles (3 + 6 GBq) of Lu-PSMA in an 8 week interval. After both cycles, dosimetry is performed of the tumors and organs at risk. Following both treatments, patients are monitored weekly for adverse events (AE), blood toxicity and PSA response. Patients receive PSMA-PET and MRI at screening & 8, 20 and 32 weeks after the first treatment injection. EORTC-QLQ-C30 (QoL) questionnaires are filled in every month till the end of the study.
Ergebnisse/Results Currently, 10 patients have been included of which 4 completed the protocol entirely. Baseline metastases ranged from 1–10 and PSA from 0.43–20 µg/l. After 6 months follow-up, none of the 4 patients that fully completed the study reported xerostomia or had significant changes on the QoL questionnaire. No high-grade (> 2) AE were observed, however 3/4 patients reported temporarily G1-2 fatigue. According to dosimetry, none of the organs at risk were in danger. Total doses to metastases ranged from 24–69 Gray per lesion. 2 of the 4 patients had a PSA response < 50 % 12 weeks after cycle 2, of which one had a complete response on PET-imaging. At time of submission, treatments of the other 6 patients are being finalized.
Schlussfolgerungen/Conclusions Lu-PSMA appears to be safe in HS PC. All 4 patients responded by at least temporarily stabilizing disease. Lu-PSMA has the potential to become a new treatment in HS PC.