NCT06830408

Performance of 177Lu-PSMA-I&T for RLT in mCRPC - Prospective Multicenter Swiss Registry Study

Swiss Cancer Registry on Safety and Efficacy of 177Lu-ITG-PSMA-1 Radionuclide Therapy in Prostate Cancer Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study (multicenter, national registry-based) is to evaluate the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I\&T) as therapy in patients with metastatic castration resistent prostate cancer (mCRPC). The main questions are whether the 177Lu-PSMA-I\&T is safe and if it works well to treat patients with progressive mCRPC. The data and information in the study are collected under standard medical therapy and follow-up, so called real-world conditions. Participants will: * undergo regular radioligand therapy (RLT) with 177Lu-PSMA-I\&T * have clinical, laboratory and imaging follow-up according to the currently available recommendation for PSMA-RLT an in line with their medical needs. * answer study related set of questionnaires

Detailed description

Prospective, multicenter Swiss registry study evaluating the performance of 177Lu-ITG-PSMA-1 (177Lu-PSMA-I\&T) as RLT in mCRPC. Primary endpoint: Safety- * frequency and severity of adverse events (measured according to CTCAE 5.0). Secondary endpoints: Efficacy * biochemical response: best PSA response, PSA50 (\>50% decrease from baseline PSA level) and PSA response at 12 weeks * imaging response: Objective response rate evaluated on follow-up morphological imaging CT/MRI and/or on molecular imaging PSMA PET/CT * quality of life: evaluated with standardized questionnaires

Conditions

• mCRPC

Interventions

Type	Name	Description
DRUG	radionuclide therapy with 177Lu-PSMA-I&T	Standard PSMA RLT with 7-8 GBq i.v. infusion of 177Lu-PSMA-I\&T performed every 6-8 weeks for 4-6 cycles, or until progression or complete response.

Timeline

• Start date: 2020-07-06
• Primary completion: 2024-11-12
• Completion: 2025-01-13
• First posted: 2025-02-17
• Last updated: 2025-02-17

Locations

8 sites across 1 country: Switzerland