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

M.D. Anderson Cancer Center

Status: Begins enrollment this month

Conditions: Lu-177 PSMA

Treatments: Other: SPECT; Drug: Lu-177

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07169825

2024-1702

NCI-2025-06603 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA

Experimental group

Treatment:

Drug: Lu-177

Other: SPECT