Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Male

Summary

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ryan Kohlbrenner, MD
• Collaborator: Radiological Society of North America
• Treatments: Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Age greater than or equal to 18 years and less than or equal to 70 years

• Children are excluded from this study because the disease does not occur in children

• Individuals over the age of 70 are excluded from this study to improve the likelihood of at least one catheterizable prostatic artery, given the higher rates of occlusive atherosclerosis with advanced age

• Ability to provide informed consent

• Biopsy-proven bilateral prostate adenocarcinoma (within 3 months of first scan), any stage (using the TNM Staging criteria, any N or any M)

• Maximal tumor diameter >= 2.0 cm on each side, documented on prostate magnetic resonance imaging (MRI) within 3 months of first scan

• Gleason score >= 4+4

• Cancer of the Prostate Risk Assessment (CAPRA) score >= 6

Exclusion Criteria:

• Body mass index (BMI) > 30 kg/m^2

• Prior treatment for prostate cancer, or any use of anti-androgen therapy within 3 months of first scan

• History of any pelvic radiotherapy

• Greater than 10 pack-year smoking history or severe atherosclerosis from prior CT imaging study, if available

• Stage IV or V chronic kidney disease by estimated glomerular filtration rate (eGFR) within 45 days of first scan

• Platelet count < 50 x 109/L and/or international normalized ratio > 1.5

• Severe allergy to iodinated contrast

• Active urinary tract infection or recent episode of prostatitis within 1 month of first scan

• Inability to tolerate prolonged supine positioning