Gallium 68 PSMA-11

(Gallium Ga 68 PSMA-11®)

Gallium 68 PSMA-11

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Drug updated on 5/17/2024

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


  • 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.

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  • Gallium 68 PSMA-11 (Gallium Ga 68 PSMA-11) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen-positive lesions in men with prostate cancer who are candidates for initial definitive therapy or have suspected recurrence based on elevated serum PSA level.
  • The information stems from a total of 13 systematic reviews and meta-analyses, focusing on the diagnostic performance, safety, effectiveness, and specificity of Gallium Ga 68 PSMA-11 across various medical conditions including primary and secondary prostate cancer scenarios.
  • In terms of diagnostic superiority in Prostate Cancer, Gallium Ga 68 PSMA-11 PET/CT showed high accuracy. It demonstrated superior sensitivity, positive predictive value, and accuracy compared to other imaging modalities when detecting bone metastases preoperatively.
  • When comparing Gallium Ga 68 PSMA-11 with other tracers like F-labeled PSMA PET/CT tracers for prostate cancer detection, it exhibited similar or slightly higher sensitivity indicating strong diagnostic performance.
  • Gallium Ga 68 PSMA-11 was found to be superior to traditional bone scintigraphy in detecting bone metastases, which further emphasizes its excellent diagnostic capabilities within the context of Prostate Cancer applications.
  • In comparison with other radiotracers such as somatostatin analogs (SSAs), Gallium labeled agents were not impacted by SSAs treatment prior to imaging, especially while dealing with neuroendocrine tumors (NETs).
  • The utility extends beyond NETs as well, where it shows higher sensitivity than FDG in detecting primary liver cancers suggesting that Gallium radiotracers may have specific advantages over traditional FDG imaging techniques.
  • Gallium Ga 68 PSMA-11 has shown equal performance when used alongside biochemical recurrence detectors such as PET/MRI, highlighting its versatility across different imaging modalities.

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-analysis.2024Clinical Nuclear Medicine
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
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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