Gallium 68 PSMA-11

(Gallium Ga 68 PSMA-11®)

Gallium 68 PSMA-11

Drug updated on 11/5/2024

Dosage FormInjection (intravenous; up to 218 MBq/mL [5.89 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 prostatespecific antigen (PSA) level

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Summary
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  • This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
  • Gallium 68 gozetotide (gozetotide, also known as PSMA-11) demonstrated high diagnostic accuracy for detecting and staging primary prostate cancer. Sensitivity and specificity were 0.87 (95% CI (confidence interval): 0.80-0.92) and 0.80 (95% CI: 0.69-0.89), respectively, compared to mpMRI. It also showed higher sensitivity for pelvic lymph node staging with a sensitivity of 0.71 (95% CI: 0.48-0.86) versus mpMRI's 0.40 (95% CI: 0.16-0.71).
  • In staging, gallium 68 gozetotide PET (positron emission tomography)/MRI (magnetic resonance imaging) showed slightly higher diagnostic accuracy for lymph node metastasis (LNM) compared to PET/CT, with a lnDOR of 4.73 (95% CI: 2.93-6.52) for PET/MRI vs. 2.42 (95% CI: 2.07-2.78) for PET/CT, indicating its effectiveness in detailed prostate cancer staging.
  • There is no safety information available in the reviewed studies.
  • Specific populations studied with gallium 68 gozetotide (PSMA-11) include patients with primary prostate cancer and those with biochemically recurrent prostate cancer (P = 0.58 (BCR)). In both groups, gallium 68 gozetotide (PSMA-11) PET/CT demonstrated high diagnostic accuracy, showing comparable effectiveness to mpMRI in primary prostate cancer detection and superior sensitivity in pelvic lymph node staging. PET/MRI showed slightly higher accuracy than PET/CT for lymph node metastasis (LNM) detection.

Product Monograph / Prescribing Information

Document TitleYearSource
Gallium 68 Gozetotide (gozetotide (also known as PSMA-11)) Prescribing Information.2022UCLA Nuclear Medicine, Los Angeles, CA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines