NCT03454750

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC)

Radiometabolic Therapy (RMT) With 177Lu PSMA 617 in Advanced Castration Resistant Prostate Cancer (CRPC): Efficacy and Toxicity Evaluation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation

Detailed description

Radiometabolic Therapy (RMT) with 177Lu PSMA 617 in advanced castration resistant prostate cancer (CRPC): efficacy and toxicity evaluation. Single-center, prospective, non controlled, open label, phase II trial. The main objective of this study is to evaluate the Disease Control Rate (DCR) and the safety as co-primary objective. The secondary objectives are: late toxicity, PFS, OS, biochemical response and dosimetry.

Conditions

• Metastatic Castration Resistant Prostate Cancer
• 68Ga-PSMA PET/CT Positive

Interventions

Type	Name	Description
DRUG	177Lu-PSMA	177Lu-PSMA 3.7-5-5 GBq Intravenous Slowly in 15-30 ' Day 1/ every 8-12 weeks Four cycles every 8-12 weeks

Timeline

• Start date: 2022-10-25
• Primary completion: 2024-05-22
• Completion: 2024-05-22
• First posted: 2018-03-06
• Last updated: 2025-01-08

Locations

1 site across 1 country: Italy