Tracer library / [18F]DCFPyL
[18F]DCFPyL
Also written as [18F]DCFPyL; [F-18]DCFPyL; DCFPyL; F-18 DCFPyL; piflufolastat; piflufolastat F18; PyL
- Radionuclide
- F-18 t½ 109.7 min
- Modality
- PET
- Production route
- Cyclotron liquid target
- Stage
- Approved
- Syntheses indexed
- 5
What it is
- Compound class
- Small molecule (urea-based)
- Target / mechanism
- Prostate-specific membrane antigen (PSMA) PMID 28283702 / DOI 10.1007/s00259-017-3670-z
- Clinical application
- Prostate cancer staging and recurrence PMID 28283702 / DOI 10.1007/s00259-017-3670-z
- Theranostic pair
- [177Lu]Lu-PSMA-617
Regulatory status
- FDA
- Yes — 2021; PYLARIFY (piflufolastat F 18); Progenics Pharmaceuticals (Lantheus); NDA 214793 Drugs@FDA, NDA 214793, approved 2021-05-26 — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process&searchTerm=piflufolastat
- EMA (centralised)
- Yes — 2023; Pylclari (piflufolastat (18F)); Curium Pet France; EMEA/H/C/005520 EMA medicines register, EPAR Pylclari, marketing authorisation issued 2023-11-27 — https://www.ema.europa.eu/en/medicines/human/EPAR/pylclari
- Other approvals
- —
- Brand names
- Pylarify (US, FDA); Pylclari (EU, EMA)
Clinical use
- Typical injected activity
- 333 MBq (9 mCi) per US prescribing information; clinical studies used ~300-321 MBq FDA prescribing information PYLARIFY (NDA 214793); PMID 31676732 / DOI 10.2967/jnumed.119.234799
- Uptake time
- 60 min post-injection (per prescribing information); studies also imaged at 1-2 h FDA prescribing information PYLARIFY (NDA 214793); PMID 35396969 / DOI 10.1007/s00259-022-05775-z
Reported in the literature. Not a dosing recommendation.
Published syntheses
| Module | Cassette | Purification | Yield % | RCP % | Precursor / supplier | Source |
|---|---|---|---|---|---|---|
| — | — | — | 5-12% (literature); >20% with direct fluorination decay-corrected | — | DCFPyL precursor | 27847991 2017 Eur J Nucl Med Mol Imaging The radiosynthesis of [68Ga]Ga-PSMA-HBED-CC [29] and [18F]DCFPyL [22] were performed according to previously reported methods and are described in the supporting information. - [18F]DCFPyL suffers from poor radiochemical yields (in the range 5–12 % decay-corrected [23, 24], although recently an improved synthesis by direct fluorination has been reported to increase yield to greater than 20 % [25] |
| TRACERlab FX FN GE HealthCare | — | HPLC | 23 ± 5 % decay-corrected | 98 % | compound 9 (trimethylammonium salt) | 27142881 2016 EJNMMI Res Automated radiosynthesis of [18F]DCFPyL was performed on a GE TRACERlabTM FXFN automated synthesis unit (ASU) equipped with an integrated HPLC system - The overall isolated radiochemical yield of [18F]DCFPyL was 23 ± 5 % (n = 10, decay-corrected). |
| FASTlab GE HealthCare | custom manifold | SPE | 25 to 37% uncorrected not corrected | 93–98% | trimethylammonium precursor of…trimethylammonium precursor of [18F]F-Py-TFP (precursor 2) and Glu-CO-Lys ABX | 35507241 2022 EJNMMI Radiopharm Chem using the FASTlab™ synthesizer - affords convenient access to the PSMA tracer [18F]DCFPyL in radiochemical yields ranging from 25 to 37% (uncorrected) |
| In-house / custom built in-house | custom manifold | HPLC+SPE | 30.9 not corrected | — | 5-(((S)-6-(tert-butoxy)-5-(3-((S)-1,5-di-ter…5-(((S)-6-(tert-butoxy)-5-(3-((S)-1,5-di-tert-butoxy-1,5-dioxopentan-2-yl)ureido)-6-oxohexyl)carbamoyl)-N,N,N-trimethylpyridin-2-aminium trifluoromethanesulfonate (3) | 27470935 2016 J Labelled Comp Radiopharm The radiotracer synthesis was performed on a custom-made radiofluorination module and the Sofie Biosciences ELIXYS. - an average radiochemical yield of 30.9% at EOS |
| ELIXYS FLEX/CHEM Sofie | vendor cassette | HPLC+SPE | 19 not corrected | — | 5-(((S)-6-(tert-butoxy)-5-(3-((S)-1,5-di-ter…5-(((S)-6-(tert-butoxy)-5-(3-((S)-1,5-di-tert-butoxy-1,5-dioxopentan-2-yl)ureido)-6-oxohexyl)carbamoyl)-N,N,N-trimethylpyridin-2-aminium trifluoromethanesulfonate (3) | 27470935 2016 J Labelled Comp Radiopharm The ELIXYS (Sofie Biosciences, Inc, Culver City, California) module is a commercially available automated multireactor radiosynthesizer. - an average radiochemical yield of 19% at EOS |
Clinical literature
Clinical studies in the indexed corpus, ordered by design (multicentre, prospective, retrospective, others, case reports last) and then by year. Titles and links only, as published; this is not a summary of the evidence.
- Does enzalutamide related PSMA upregulation affect outcomes of lutetium-177 PSMA radioligand therapy?2024 · Urologia · Retrospective
- The Clinical Utility of 18F-Fluciclovine PET/CT in Biochemically Recurrent Prostate Cancer: an Academic Center Experience Post FDA Approval.2021 · Mol Imaging Biol · Retrospective
- Leveraging [18F]F-Piflufolastat PET for PBPK Prediction of Tissue Distribution and Therapy Optimization in Prostate Cancer.2026 · Clin Transl Sci · Clinical study
- 61Cu-NODAGA Prostate-specific Membrane Antigen Imaging and Therapy for Prostate Cancer: Phase 1 Trial of a New Class of 61Cu-labeled PET Radiotracers.2025 · Radiology · Clinical study · Phase I
- Deep Learning for Automated Measures of SUV and Molecular Tumor Volume in [68Ga]PSMA-11 or [18F]DCFPyL, [18F]FDG, and [177Lu]Lu-PSMA-617 Imaging with Global Threshold Regional Consensus Network.2025 · J Nucl Med · Clinical study
- Clinical Trial Protocol for VIOLET: A Single-Center, Phase I/II Trial Evaluation of Radioligand Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer with [161Tb]Tb-PSMA-I&T.2024 · J Nucl Med · Clinical study · Phase I/II
- A phase 2, single-arm trial evaluating 131 I-PSMA-1095 targeted radioligand therapy for metastatic castration-resistant prostate cancer.2024 · Nucl Med Commun · Clinical study · Phase II
- PSMA-Hornet: Fully-automated, multi-target segmentation of healthy organs in PSMA PET/CT images.2024 · Med Phys · Clinical study
- PSMA- and GRPR-Targeted PET: Results from 50 Patients with Biochemically Recurrent Prostate Cancer.2021 · J Nucl Med · Clinical study
Precursor
- Common precursor
- Glu-CO-Lys (Glu-urea-Lys) pseudo-peptide precursor (2-step with [18F]F-Py-TFP prosthetic group); or the trimethylammonium-nicotinic-acid-conjugated Glu-CO-Lys precursor for direct 1-step labelling PMID 35507241 / DOI 10.1186/s41181-022-00157-0
- Suppliers seen in the literature
- ABX GmbH (Radeberg, Germany) or Scintomics GmbH (Fuerstenfeldbruck, Germany)
- Cited suppliers in indexed syntheses
- ABX
- Typical final purification
- —
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Get in touchQuality control Derived from the published synthesis
- Ph. Eur. monograph
- no monograph none (general monograph 0125 applies)
- USP monograph
- not verified the USP-NF monograph index is subscription-only and no public confirmation was found
How this set was arrived at. Cross-checked against Ph. Eur. general monograph 0125 (base set), EANM validation guideline (PMC7016057) and cGRPP guidance (PMC7881071). Draft X-marks consistent with the base set; tracer-specific analytical tests follow the specific monograph where one exists.
Tests listed by reference only. Monograph texts are copyrighted and are not reproduced here. How these are derived
Setting up quality control?We can help you scope the equipment needed to release [18F]DCFPyL.
Get in touchNotes
One published route uses the [18F]F-Py-TFP prosthetic group.