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

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.

• Lu-177 (Drug): Given by IV
• SPECT (Other): SPECT/CT

Primary outcomes

• 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

Sex: Male

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.

• Guofan Xu, MD, Principal investigator, M.D. Anderson Cancer Center