Drug updated on 3/28/2024
| Dosage Form | Injection (intravenous; (1 mCi/mL-80 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 prostate-specific antigen (PSA) level.
Summary
- Piflufolastat F 18 (Pylarify) is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer who are suspected to have metastasis and are candidates for initial definitive therapy.
- The drug is also used in PET imaging of PSMA positive lesions in men with prostate cancer that shows signs of recurrence based on elevated serum levels of the biomarker, Prostate-Specific Antigen (PSA).
- A total of three systematic reviews/meta-analyses were reviewed which provided insights into the effectiveness and safety profile of Piflufolastat F 18.
- One study found that the pooled sensitivity, specificity, and Area Under Curve values for 18F-PSMA PET/CT diagnosis using Pylarify were high at 0.93, 0.94, and 0.96 respectively indicating its potential as a critical diagnostic tool for detecting recurrence or metastasis in patients with Biochemical Recurrence Prostate Cancer(BRPca).
- Another review suggested that this drug has a relatively high detection rate especially when PSA levels are above .5 ng/ml making it an effective first-line imaging modality even during early detection stages.
- Despite some heterogeneity among studies included within these meta-analyses all agreed upon the good sensitivity and specificity rates associated with piflufolastat F-18's use suggesting its strong clinical value but further large-scale multicenter studies may be needed to validate these findings fully.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pylarify (piflufolastat F 18) Prescribing Information. | 2023 | Progenics Pharmaceuticals, Inc., Billerica, MA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Diagnostic performance of 18F-labeled PSMA PET/CT in patients with biochemical recurrence of prostate cancer: a systematic review and meta-analysis. | 2023 | Acta Radiologica |
| Performance of 18F-DCFPyL PET/CT imaging in early detection of biochemically recurrent prostate cancer: a systematic review and meta-analysis. | 2021 | Frontiers in Oncology |
| Evaluation of 18F-DCFPyL PSMA PET/CT for prostate cancer: a meta-analysis. | 2021 | Frontiers in Oncology |