Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07169825

Enrollment

Registered

2025-09-12

Start date

2026-03-30

Completion date

2028-09-01

Last updated

2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lu-177 PSMA

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.

Detailed description

Primary Objectives • To determine the personalized radiation dose to tumors and critical organs of participants with compromised renal and / or bone marrow function. Secondary Objectives * To compare target radiation doses based on varying SPECT scan duration. Plot the variability in target radiation dose versus scan duration. * To compare the image quality and dosimetry results when considering the low, high, and both energy peaks of Lu-177. * To compare target radiation doses based on multiple imaging time points versus a single time point and identify which time point is most suited for this evaluation. * To compare target radiation doses derived from organ versus voxel dosimetry calculation.

Interventions

DRUGLu-177

Given by IV

OTHERSPECT

SPECT/CT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

Eligibility Criteria * Participants that are approved for Pluvicto therapy and have been identified to have renal complications or compromised marrow function. Renal complication is defined as GFR: 30-50ml/min, creatinine: ULN-twofold ULN; while compromised marrow function is indicated by total WBC 2.5 x 109 L - LLN, or platelet count 75-100 x 109 L. * Participants who agree to be imaged multiple times as defined in the study protocol.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
safety and adverse events (AEs).	Through study completion; an average of 1 year	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Countries

United States

Contacts

CONTACTGuofan Xu, MD

gxu2@mdanderson.org713-745-9017

PRINCIPAL_INVESTIGATORGuofan Xu, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026