N/A
N=10
MSG Use With 18F-DCFPyL PET/CT Imaging
Prostate Cancer · Prostate Cancer Metastatic · Prostatic Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03693742 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL — 9.9; 15.1 SULmax — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 18F-DCFPyL PET/CT scan (Diagnostic_test); Placebo drink (Other); MSG drink (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- British Columbia Cancer Agency
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Salivary Gland Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL |
9.9; 15.1 | <0.001 sig |
| SECONDARY Renal Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL |
27.4; 37.5 | — |
| SECONDARY Tumour Maximal Standardized Uptake Values Corrected for Lean Body Mass (SULmax) for 18F-DCFPyL |
2.8; 4.4 | — |
| SECONDARY Number of Participants With Tomato Juice (Containing Either MSG or Placebo) Related Adverse Events as Assessed by Abnormal Vital Sign Measurement. |
0; 0 | — |
Summary
18F-DCFPyL is an agent that binds to prostate specific membrane antigen (PSMA). Due to high levels of PSMA in prostate cancer, treatments targeting PSMA have been developed to deliver therapy to these specific target cells. Unfortunately when this treatment is delivered there is radiotracer uptake in the salivary glands and kidneys, not related to cancer, which causes dry mouth and causes patients to stop treatment. It is proposed that having tomato juice containing monosodium glutamate (MSG) may reduce radiotracer uptake in the salivary glands and kidneys and reduce damage to these tissues.
Eligibility Criteria
Inclusion Criteria
- Known prostate cancer with biochemical recurrence after initial curative therapy with radical prostatectomy, presenting with a prostate specific antigen (PSA) greater than 0.4 ng/mL.
- Subjects with findings on other examinations (such as plain x-ray, CT, MRI or bone scintigraphy and others) that are suspicious for metastatic disease but not conclusively diagnostic of metastatic disease, within 3 months of PET scan.
- Known prostate cancer with biochemical recurrence after initial curative therapy with radiation therapy (including brachytherapy), with a PSA level >2 ng/mL above the nadir after radiation therapy.
- Castration resistant prostate cancer with a minimum PSA of 2.0 ng/mL with 2 consecutive rises above the nadir and castrate levels of testosterone (<1.7 nmol/L). Treatment does not need to be discontinued before the 18F-DCFPyL scan.
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less.
Exclusion Criteria
- Medically unstable (eg. acute illness, unstable vital signs)
- Unable to lie supine for the duration of imaging
- Unable to provide written consent
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
- 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
- History of severe asthma that has led to hospitalizations or emergency room visits
- History of intolerance to MSG
- History of severe headaches or migraines triggered by food or MSG
- Participants on a sodium/salt restricted diet due to other medical conditions
- No new treatment has started between the first and second 18F-DCFPyL PET/CT
Data sourced from ClinicalTrials.gov (NCT03693742). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.