Gallium 68 PSMA-11

(Gallium Ga 68 PSMA-11®)

Gallium 68 PSMA-11

Drug updated on 4/29/2024

Dosage FormInjection (intravenous; 18.5 MBq/mL to 185 MBq/mL [0.5 mCi/mL to 5 mCi/mL])
Drug ClassRadioactive 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 prostate cancer with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Summary
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  • 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 TitleYearSource
Gallium 68 PSMA-11 (Gallium 68 PSMA-11) Prescribing Information.2020University of California, Los Angeles, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Comparative study of different imaging modalities for diagnosis of bone metastases of prostate cancer: a Bayesian network meta-analysis2024Clinical Nuclear Medicine
Head-to-head comparison of 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI in the detection of biochemical recurrence of prostate cancer: summary of head-to-head comparison studies.2023Prostate Cancer and Prostatic Diseases
Effects of somatostatin analogs on uptake of radiolabeled somatostatin analogs on imaging: a systematic review and meta-analysis.2023Quantitative Imaging in Medicine and Surgery
Diagnostic value of 18F-FDG PET/CT and 68Ga-FAPI PET/CT in primary liver cancer: a systematic review and meta-analysis.2023Hellenic Journal of Nuclear Medicine
Meta-analysis of 18 F-PSMA-1007 PET/CT, 18 F-FDG PET/CT, and 68Ga-PSMA PET/CT in diagnostic efficacy of prostate Cancer.2023Cancer Imaging
Comparison of 18F-based PSMA radiotracers with [68Ga]Ga-PSMA-11 in PET/CT imaging of prostate cancer-a systematic review and meta-analysis.2023Prostate Cancer and Prostatic Diseases
A systematic review on combined [18F]FDG and 68Ga-SSA PET/CT in Pulmonary Carcinoid.2023Journal of Clinical Medicine
Head-to-head comparison of 68Ga-FAPI PET/CT and FDG PET/CT for the detection of peritoneal metastases: systematic review and meta-analysis.2023American Journal of Roentgenology
Head-to-head comparison of 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI in the detection of biochemical recurrence of prostate cancer: summary of head-to-head comparison studies.2023Prostate Cancer and Prostatic Diseases
Head-to-head comparison of 68Ga-PSMA-11 PET/CT and 99mTc-MDP bone scintigraphy for the detection of bone metastases in patients with prostate cancer: a meta-analysis.2022American Journal of Roentgenology
Head-to-head comparison of 68Ga-PSMA-11 PET/CT and 99mTc-MDP bone scintigraphy for the detection of bone metastases in patients with prostate cancer: a meta-analysis.2022American Journal of Roentgenology
68Ga-PSMA PET/MRI for the diagnosis of primary and biochemically recurrent prostate cancer: a meta-analysis.2020European Journal of Radiology
Diagnostic accuracy of 68Ga-PSMA PET/CT for initial detection in patients with suspected prostate cancer: a systematic review and meta-analysis.2020American Journal of Roentgenology
Performance of [68Ga] Ga-PSMA 11 PET for detecting prostate cancer in the lymph nodes before salvage lymph node dissection: a systematic review and meta-analysis. 2020Prostate Cancer and Prostatic Diseases
Gallium-68 prostate-specific membrane antigen positron emission tomography in advanced prostate cancer—Updated diagnostic utility, sensitivity, specificity, and distribution of prostate-specific membrane antigen-avid lesions: a systematic review and meta-analysis.2020European Urology

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