NCT07169825

Brief Summary

To determine the dose of Pluvicto therapy absorbed in the tumors and organs of patients whose kidneys and/or bone marrow are not working properly.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
29mo left

Started Mar 2026

Typical duration for not_applicable

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 Progress4%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

September 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

September 5, 2025

Last Update Submit

March 31, 2026

Conditions

Lu-177 PSMA

Outcome Measures

Primary Outcomes (1)

  • safety and adverse events (AEs).

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Through study completion; an average of 1 year

Study Arms (1)

Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA

EXPERIMENTAL
Drug: Lu-177Other: SPECT

Interventions

Lu-177DRUG

Given by IV

Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA
SPECTOTHER

SPECT/CT

Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMales
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Pluvicto therapy patients without renal or marrow function complications
  • Participants who do not wish to be imaged multiple times as per the study protocol.
  • Women and children since this is treatment for prostate cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Interventions

Lutetium-177

Study Officials

  • Guofan Xu, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guofan Xu, MD

CONTACT

713-745-9017gxu2@mdanderson.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 12, 2025

Study Start

March 30, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

April 2, 2026

Record last verified: 2026-03

Locations

US(1)