Overview
DCFPYL (also known as 18F-DCFPyL or PSMA-11) is a fluorine-18-labeled radiopharmaceutical designed for prostate-specific membrane antigen (PSMA)-targeted PET imaging. It binds selectively to PSMA, a protein overexpressed in prostate cancer cells, enabling high-resolution detection of primary and metastatic tumors. Developed as an alternative to older tracers like 68Ga-PSMA-11, it offers longer half-life (110 minutes vs. 68 minutes) and improved logistics for clinical use. Approved by the FDA in 2021, DCFPYL has become a cornerstone in prostate cancer diagnostics, particularly for biochemical recurrence. Its adoption reflects the growing emphasis on precision oncology and molecular imaging in urology and radiology practices worldwide.
Physical and Chemical Properties
DCFPYL is a small-molecule inhibitor with a molecular weight of 503.47 g/mol, formulated as a sterile, pyrogen-free solution for intravenous injection. The compound exhibits high hydrophilicity due to its urea-based scaffold and carboxylate groups, ensuring rapid clearance from non-target tissues. The fluorine-18 isotope emits positrons with a maximum energy of 0.635 MeV, ideal for PET detection. Critical quality attributes include radiochemical purity (>95%), specific activity (>10 GBq/μmol), and pH (5.0-7.5). Stability studies indicate a 6-hour shelf life post-radiosynthesis when stored at room temperature with light protection. Residual solvents like acetonitrile must meet ICH Q3C guidelines (<410 ppm).
Main Applications
DCFPYL PET/CT scans are primarily indicated for: 1) Localizing recurrent prostate cancer in patients with rising PSA levels post-treatment, 2) Staging high-risk primary prostate cancer, and 3) Assessing eligibility for PSMA-targeted therapies like 177Lu-PSMA-617. Studies show superior sensitivity (85-92%) compared to conventional imaging (CT/MRI) in detecting lymph node and bone metastases. Off-label uses include monitoring treatment response and guiding biopsy procedures. Research explores expanded applications in other PSMA-expressing cancers (e.g., renal cell carcinoma) and theranostic approaches combining diagnostic (18F-DCFPyL) and therapeutic (177Lu-PSMA) agents.
Safety and Storage
As a radioactive compound, DCFPYL requires strict adherence to ALARA (As Low As Reasonably Achievable) principles. Personnel must wear dosimeters and use lead shielding during preparation/administering. Common adverse effects (<2% incidence) include mild nausea, headache, or injection site reactions. Pregnancy and breastfeeding are absolute contraindications due to fetal radiation risks. Storage mandates compliance with nuclear regulatory standards—typically in lead-shielded containers at 20-25°C. Transportation follows IAEA Type A package regulations with temperature monitoring. Institutions must maintain radiation safety protocols including spill kits and waste disposal procedures for contaminated materials.
B2B Procurement Guide
Procuring DCFPYL involves: 1) Verifying supplier accreditation (e.g., FDA/EU GMP certification for radiopharmaceuticals), 2) Ensuring logistics support for time-sensitive deliveries (half-life constraints), and 3) Confirming batch-specific quality control documentation (radio-TLC/HPLC reports). Bulk purchasing agreements with cyclotron facilities can reduce costs by 15-20%. Key selection criteria include production capacity (≥10 batches/week), geographic coverage (≤4-hour transport radius), and value-added services like dose calibration. Emerging markets may face supply chain challenges; dual-sourcing from regional producers (e.g., Asia-Pacific radiopharmacies) mitigates risks. Budgeting should account for ancillary costs—shielding equipment, staff training, and regulatory filings.
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