68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer

PRIMARY OBJECTIVE:

I. To overcome a clinical access issue that would otherwise block patients from reimbursement of a new cancer therapy, and therefore block or significantly delay their care.

OUTLINE:

Patients receive gallium Ga 68 gozetotide intravenously (IV) and then undergo a positron emission tomography (PET)/computed tomography (CT) scan throughout the trial.

Inclusion criteria

• An adult male patient who is actively under the care of a medical oncology, radiation oncology or urology physician at Mayo Clinic
• An adult male patient who is deemed eligible (or potentially/likely eligible) for PSMA-targeted radionuclide therapy by a nuclear medicine physician or Radiologist in the nuclear medicine therapy practice, or by the Prostate Theranostic Tumor Board (PTuB)

• Eligibility will be documented in the medical record by the clinical practice
• It is acceptable for the patient to be eligible for PSMA-targeted radionuclide therapy in all regards except for having completed a PSMA-targeted PET scan showing PSMA-positive prostate cancer
• It is acceptable for a patient to be potentially eligible for therapy, but have a relative contraindication, such as a minor laboratory abnormality, and be on the list for discussion at the PTuB in the future
• An adult male patient who has not received a 68Ga-PSMA-11 PET/CT or PET/magnetic resonance (MR), or for whom a repeat 68Ga-PSMA-11 PET/CT exam is needed per the clinical practice to ensure eligibility
• An adult male patient who does not otherwise have access to a reimbursable clinical 68Ga-PSMA-11 PET scan
• An adult above the ages of 18

Exclusion criteria

• A patient who is unable to consent per Mayo guidelines
• A patient who is unable to lay still, or otherwise successfully complete the imaging exam