Drug updated on 12/11/2024
Dosage Form | Injection (intravenous; up to 218 MBq/mL [5.89 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 prostate cancer with suspected recurrence based on elevated serum prostatespecific antigen (PSA) level
Latest News
Summary
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Gallium 68 gozetotide (gozetotide, also known as prostate-specific membrane antigen (PSMA)-11) demonstrated high diagnostic accuracy for detecting and staging primary prostate cancer. Sensitivity and specificity were 0.87 (95% confidence interval (CI): 0.80-0.92) and 0.80 (95% CI: 0.69-0.89), respectively, compared to multi-parametric magnetic resonance imaging (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 positron emission tomography (PET)/magnetic resonance imaging (MRI) 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 (BCR) (P = 0.58). 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 LNM detection.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Gallium 68 Gozetotide (gozetotide (also known as PSMA-11)) Prescribing Information. | 2022 | UCLA Nuclear Medicine, Los Angeles, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
SNMMI Procedure Standard/EANM Practice Guideline for SSTR PET: Imaging Neuroendocrine Tumors | 2023 | Journal of Nuclear Medicine |