SPECT/CT Imaging for Dosimetry in 177Lu-PSMA-617 (Pluvicto) Therapy

Recruiting

• Conditions: Metastatic Castration-Resistant Prostate Carcinoma

• Registration Number: NCT07096999
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

This study is being performed to establish the association between absorbed dose to tumor and response and absorbed dose to normal organs and toxicity following Lu177-PSMA radioligand therapy

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-23
• Status Verified: 2025-07
• Study First Submitted: 2025-07-08
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Primary Completion: 2031-01-23
• Study Completion: 2031-01-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• * 177Lu-617 PSMA treatment scheduled for mCRPC

  • Clinically stable as determined by the nuclear medicine clinicians
  • Male
  • ≥ 18 years of age
  • Willing and able to provide informed consent

Exclusion Criteria

• Patients who are unable to lie flat on the imaging systems long enough to permit imaging protocols to be performed

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response and toxicity following 177Lu-RLT	Up to 4 years	Association between absorbed dose and effect (response/toxicity) following 177Lu-RLT

Secondary Outcome Measures

Name	Time	Method
Build and test models	Up to 4 years	Build and test models for predicting therapy delivered absorbed dose from pre-therapy PET imaging/non-imaging biomarkers.

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States