Impact of Monosodium Glutamate on 68GA-PSMA-11, PET Imaging Biodistribution in Patients With Prostate Cancer

• Status: Completed
• Trial end date: 2020-05-06
• Target enrollment: 0
• Participant gender: Male

Summary

This phase I trial studies the impact of monosodium glutamate (MSG) on 68GA-PSMA-11 PET/CT in decreasing the salivary glands uptake in patients with prostate cancer. Prostate specific membrane antigen (PSMA) is a molecule that is overexpressed by the prostate cancer cells. 68GA-PSMA-11 is an imaging radioactive drug that can target this molecule in tissues for imaging and therapy of prostate cancer. Food substances, such as monosodium glutamate, may reduce salivary gland uptake of 68GA-PSMA-11. Ultimately, giving MSG may reduce potential harm and injury to the salivary glands in patients with prostate cancer treated with PSMA-targeted molecular radiotherapy.

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

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Edetic Acid; Gallium 68 PSMA-11

Criteria

Inclusion Criteria:

• Patient volunteer to undergo 2 PSMA PET/CT scans within 14 days

• Histopathologically proven prostate cancer (PCa)

• PSMA PET/CT indicated for :

• Initial staging before definitive therapy

• Biochemical recurrence localization

• Metastatic disease re-staging

• Ability to understand a written informed consent document and the willingness to sign it

• Ability to ingest 300 mL of fluid across 10 minute period

Exclusion Criteria:

• Prior salivary gland surgery or radiation therapy

• Prior history or current salivary gland disease

• Unable to lie flat, still or tolerate a PET scan

• Unable to follow the salivary flow stimuli administration regimen

• Unable to follow the glutamate supplementation administration regimens

• Asthma

• Severe uncontrolled hypertension (systolic blood pressure above 140 mm Hg and diastolic blood pressure above 90 mm Hg, or systolic blood pressure above 180 mm Hg, or diastolic blood pressure above 110 mg Hg). Patients with controlled hypertension under medication are eligible

• Sodium/salt restricted diet due to other medical conditions

• History of severe asthma that has led to hospitalizations or emergency room visits

• History of severe contraindications to MSG consumption including severe headaches, migraines or other intolerance

• Change to treatment administered between time of baseline scan and MSG scan