NCT07096999

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
57mo left

Started Jan 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Jan 2025Jan 2031

Study Start

First participant enrolled

January 23, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2031

Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

6 years

First QC Date

July 8, 2025

Last Update Submit

July 24, 2025

Conditions

Metastatic Castration-Resistant Prostate Carcinoma

Keywords

Prostate Cancer177LuPSMAmCRPCRadioligand Therapy

Outcome Measures

Primary Outcomes (1)

  • Response and toxicity following 177Lu-RLT

    Association between absorbed dose and effect (response/toxicity) following 177Lu-RLT

    Up to 4 years

Secondary Outcomes (1)

  • Build and test models

    Up to 4 years

Study Arms (1)

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.

Other: Non-Interventional Study

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Observational

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with mCRPC undergoing 177Lu-PSMA-617 treatment at the University of Michigan

You may qualify if:

  • \* 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Yuni K Dewaraja

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 31, 2025

Study Start

January 23, 2025

Primary Completion (Estimated)

January 23, 2031

Study Completion (Estimated)

January 23, 2031

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations

US(1)