Recruiting

Lu177-PSMA

Sponsor:

University of Michigan Rogel Cancer Center

Code:

NCT07096999

Conditions

Metastatic Castration-Resistant Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

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

Conditions

Metastatic Castration-Resistant Prostate Carcinoma

Study ID

NCT07096999

Start date

Jan 23, 2025

Status verified date

Jul, 2026

Completion date

Jan 23, 2031

Anticipated

Primary completion date

Jan 23, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

Patients receive standard care Pluvicto and undergo Lu-177 SPECT/CT scans on study. Patients may also undergo optional 99mTc-SC SPECT/CT scan for bone marrow dosimetry prior to cycle 1. In addition, patients have their medical records reviewed on study.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Response and toxicity following 177Lu-RLT [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Locations

University of Michigan Comprehensive Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

James Pool

734-615-7391jampool@med.umich.edu

Principal Investigator:

Yuni K. Dewaraja

More Information

Sponsor

University of Michigan Rogel Cancer Center

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Prostate Cancer
  • 177Lu
  • PSMA
  • mCRPC
  • Radioligand Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan Rogel Cancer Center on 2026-07-27.