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

M.D. Anderson Cancer Center25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Lu-177 PSMA

Interventions

Lu-177DRUG

Given by IV

SPECTOTHER

SPECT/CT

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Through study completion; an average of 1 year

Central Contacts

Guofan Xu, MD

CONTACT

713-745-9017 gxu2@mdanderson.org

Data from ClinicalTrials.gov

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