Drug updated on 10/25/2024
| Dosage Form | Injection (intravenous; 37 MBq/ mL to 2,960 MBq/mL [1 mCi/mL to 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.
Latest News
Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- A significantly higher overall detection rate of 58% for [(18)F]DCFPyL was demonstrated compared to 40% for [(18)F]fluoromethylcholine in patients with rising PSA levels after initial therapy (p < 0.0001).
- The detection rate of [(18)F]DCFPyL increased with higher PSA levels, reaching 88% for PSA > 2.0 ng/ml, compared to 68% for [(18)F]fluoromethylcholine, showing superior effectiveness across all PSA subgroups.
- In 44% of cases [(18)F]DCFPyL impacted patient management, compared to 29% with [(18)F]fluoromethylcholine, demonstrating a greater influence on clinical decision-making.
- No drug-related adverse events were reported for either [(18)F]DCFPyL or [(18)F]fluoromethylcholine.
- No serious adverse events were observed for either drug in the study population.
- The study enrolled men with rising PSA levels following initial curative therapy, with 73% of participants having undergone radical prostatectomy (median PSA = 0.46 ng/ml) and 27% having undergone radiation therapy (median PSA = 4.23 ng/ml).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Pylarify (piflufolastat F 18) Prescribing Information. | 2023 | Progenics Pharmaceuticals, Inc., N. Billerica, MA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| [(18)F]DCFPyL PET/CT versus [(18)F]fluoromethylcholine PET/CT in Biochemical Recurrence of Prostate Cancer (PYTHON): a prospective, open label, cross-over, comparative study | 205Subjects F: 0% M: 100% | 2023 | European Journal of Nuclear Medicine and Molecular Imaging |
Sex Distribution:
F:0%
M:100%
205Subjects
Year:
2023
Source:European Journal of Nuclear Medicine and Molecular Imaging