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

Completed · Early Phase 1

Conditions studied: Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT04282824

Run by

Jonsson Comprehensive Cancer Center

People needed

14

Starts

2019-06-05

Expected to finish

2020-05-06

Last updated by the study team

2020-12-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA / Jonsson Comprehensive Cancer Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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