Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous: 18.5 MBq/mL to 185 MBq/mL (0.5 mCi/mL to 5 mCi/mL)) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy.
- Indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Summary
- Gallium 68 PSMA-11 (Gallium 68 PSMA-11) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen positive lesions in men with prostate cancer who are suspected to have metastasis and are candidates for initial definitive therapy.
- It is also used in PET imaging of patients with suspected recurrence based on elevated serum prostate-specific antigen levels, providing valuable information about the presence and location of recurrent disease.
- A systematic review and meta-analysis involving five studies found that both Gallium 68 PSMA-11 PET/CT and PET/MRI had equivalent performance in detecting biochemical recurrence in prostate cancer, suggesting its potential utility as a diagnostic tool regardless of the imaging modality used.
- Another study compared the diagnostic performance of Gallium 68 PSMA-11 PET/CT with traditional bone scintigraphy using Tc-MDP for detection of bone metastases; it was found that Ga-PSMA-PET/CT outperformed Tc-MDP BS, indicating its superior accuracy especially when considering per-patient basis analysis.
- In total, six systematic reviews or meta-analyses were reviewed which included data from various studies assessing different aspects such as primary diagnosis, biochemical recurrence detection rate at varying PSA levels, comparison against other modalities like Bone Scintigraphy etc., all pointing towards high sensitivity and specificity profiles offered by this drug compound.
- The use of Gallium 68 PSMA-11 has been shown to be highly accurate not only during initial diagnosis but also during salvage lymph node dissection procedures where it can help identify patients likely to benefit from these interventions due to its ability to accurately detect lymph node disease post local treatment failure or biochemically recurrent cases after curative intent treatments for Prostate Cancer.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Gallium 68 PSMA-11 (Gallium 68 PSMA-11) Prescribing Information. | 2021 | University of California, Los Angeles, CA |