Piflufolastat F 18
A fluorine-18 PSMA scan agent that shows where prostate cancer is, so doctors can plan treatment
Piflufolastat F 18, studied for years as 18F-DCFPyL, is a small radioactive molecule that attaches to PSMA, a protein found in large amounts on most prostate cancer cells, so that a PET scanner can show where the cancer sits in the body. It is given once, as an injection in a hospital imaging department, and it is not something anyone can buy or use outside that setting.
Manufacturer's recommended dosing (FDA label): 333 MBq (9 mCi); acceptable range 296-370 MBq (8-10 mCi), Single injection, Intravenous bolus Details ↓
Recommended Dosing
Manufacturer's recommended dosing (FDA label)
From the prescribing information. Other doses studied, if any, are in the full dosing data below.
What is it?
A PSMA PET scan works like a homing signal. The patient receives a tiny amount of a molecule built to find one target, here prostate-specific membrane antigen (PSMA), a protein that sits in large amounts on the surface of most prostate cancer cells. The molecule carries a radioactive atom. As that atom decays it releases positrons, and the PET scanner records the gamma rays they produce and turns them into a three-dimensional map of where the molecule has gathered. Laid over a CT scan, the map can point to cancer deposits that are too small, or look too ordinary, for CT or a bone scan to flag. Doctors call these agents radioligands: a ligand that binds a target, with a radioactive label attached.
Piflufolastat F 18 is one of these agents. Chemically it is a small molecule rather than a peptide chain: a glutamate-urea-lysine core that fits PSMA's binding pocket, joined to a pyridine ring that holds the fluorine-18. It sits in peptide lists because it belongs to the same family of PSMA ligands as gozetotide (PSMA-11), the gallium-68 tracer that has its own entry. Fluorine-18 is made in a cyclotron and loses half its radioactivity every 110 minutes, so each batch has to be used within about 10 hours of being made. It is a prescription diagnostic drug handled only by trained nuclear medicine staff. No version of it can be bought, injected at home or used for anything except a scan.
FDA approved it as Pylarify in May 2021 for two groups of men with prostate cancer: those with suspected spread who are candidates for a first curative treatment, and those whose PSA is rising again after treatment. A second US product with the same active ingredient, Pylarify TruVu, was approved in March 2026, and the EU authorised it as Pylclari in November 2023. The approvals rested on two trials. In OSPREY, among men with high-risk cancer booked for surgery, the scan correctly cleared nearly 98% of the men whose pelvic lymph nodes were free of cancer, but it picked up only about 40% of the men whose nodes surgery showed to hold cancer. In CONDOR, 208 men with rising PSA and unrevealing standard scans, when the scan pointed to disease it was confirmed at the same site in 85 to 87% of cases, and about two in three had their planned treatment changed.
Head to head with older tracers it has done well. In PYTHON, a randomised crossover trial at 22 European sites, it found the returning cancer in 58% of 201 men against 40% with fluoromethylcholine, and it changed management more often. A Dutch study of men with low PSA after robotic prostatectomy found it positive in 44% against 24% with fluciclovine. In an Ontario registry of 1,289 men it found disease in 65%, from 38% when PSA was under 0.5 ng/mL to 83% above 1.0 ng/mL, and planned treatment changed in 58%. A pooled analysis of 17 studies and 2,252 men put its detection rate in recurrent disease at about 73%, again higher at higher PSA.
Its limits are the shared limits of PSMA PET. Small lymph node deposits are missed: in the Dutch SALT trial it caught 41% of the men whose nodes held cancer, so it cannot replace removing the nodes when surgeons need to stage them. PSMA is also made by some other cancers and some benign tissue, which is why the label warns about misreading images; researchers have even used the tracer to find more deposits of kidney cancer than standard imaging did. And because about half of the injected radioactivity leaves in the urine within eight hours, the bladder glows brightly and can hide a recurrence beside it. In a 2026 study of 55 men scanned with both agents, bladder activity was about a third as high with flotufolastat, which was also positive in more of the men.
On the day, the label calls for 333 MBq (9 mCi), within a range of 296 to 370 MBq, given as one injection into a vein. Imaging starts about an hour later and should not begin more than 90 minutes after the injection. Patients drink water before and after and empty the bladder just before the scan. In a dosimetry study of nine men, the effective radiation dose was 0.017 mSv per MBq, and the tear glands, salivary glands and kidneys received the most. Hormone therapy did not lower its accuracy in an OSPREY subgroup, although the label notes that drugs acting on the androgen pathway can change how much tracer tumours take up.
Mechanism of Action
Piflufolastat F 18 carries fluorine-18 to prostate-specific membrane antigen, so cancer that carries PSMA shows on a PET scan.
PSMA binding
A glutamate-urea-lysine core binds the enzyme pocket of PSMA on prostate cancer cells.
Positron imaging
Fluorine-18 decays by positron emission with a 109.8-minute half-life; the paired 511 keV gamma rays are what the PET scanner detects.
Distribution and clearance
Within an hour it is found in kidneys (16.5% of the dose), liver (9.3%) and lung (2.9%); blood levels fall with a 3.5-hour elimination half-life, and about half leaves in urine within 8 hours (label 12.3).
Published Research
The studies behind piflufolastat F 18 (18F-DCFPyL), read from their PubMed abstracts. All are studies of the scan in people with cancer, mostly prostate cancer.
CONDOR: recurrence after normal standard scans
In 208 men with rising PSA (median 0.8 ng/mL) and uninformative conventional imaging, the correct localisation rate across three readers was 84.8% to 87.0%, meeting the primary endpoint; at least one lesion was seen in 59% to 66%, and intended management changed in 63.9%.
OSPREY: staging before surgery and suspected spread
In 252 evaluable high-risk men before prostatectomy, median specificity for pelvic node disease was 97.9% but sensitivity was 40.3%, missing its endpoint; in 93 men with suspected metastases, sensitivity for biopsied lesions was 95.8% with a positive predictive value of 81.9%.
PYTHON: against fluoromethylcholine
In a randomised crossover trial at 22 European sites, 201 men with a first biochemical recurrence had both scans within 12 days; 58% were positive with 18F-DCFPyL against 40% with fluoromethylcholine, management changed in 44% against 29%, and no drug-related or serious adverse events occurred.
Against fluciclovine at low PSA
In 50 men with PSA between 0.2 and 2.0 ng/mL after robotic prostatectomy, both scans done within 15 days, 44% were positive with 18F-DCFPyL against 24% with fluciclovine, mainly because it found more pelvic lymph node disease (22% against 8%).
Ontario registry of 1,289 men
In men with biochemical failure and up to four disease sites on CT and bone scan, the scan found disease in 65% (62% of those with negative conventional imaging), rising from 38% at PSA under 0.5 ng/mL to 83% above 1.0 ng/mL; planned management changed in 58%, often from palliative to potentially curative intent.
Meta-analysis in recurrent disease
Across 17 studies and 2,252 men with biochemical recurrence, the pooled detection rate was 73%, lower than an earlier pooled estimate of 81%; positivity rose with PSA level but was not linked to PSA doubling time.
SALT: node staging before surgery
In 117 men who then had robotic prostatectomy with extended lymph node dissection, the scan's patient-level sensitivity for pelvic node metastases was 41.2% and specificity 94.0%; the authors concluded it cannot replace node dissection for staging.
Against flotufolastat in the same men
In 55 men with PSA of 0.5 ng/mL or less after prostatectomy, scanned with each agent 1 to 10 days apart, median bladder activity was 29.0 with piflufolastat against 10.9 with flotufolastat, and patient-level detection was 27.3% against 45.5%.
Against gallium-68 PSMA-11
In 14 men with relapsed prostate cancer scanned with both, every lesion seen with the gallium-68 tracer was also seen with 18F-DCFPyL, which showed extra lesions in three men and higher uptake in matching lesions.
Against fluorine-18 PSMA-1007
Twelve newly diagnosed men received about 250 MBq of each tracer 48 hours apart; both found the same lesions with similar tumour uptake, while 18F-DCFPyL showed more activity in kidneys, bladder and tear glands and PSMA-1007 more in liver, spleen and salivary glands.
Radiation dosimetry
In nine men with metastatic prostate cancer given about 321 MBq, the lacrimal glands received the highest absorbed dose per unit of activity, followed by the submandibular glands, kidneys, bladder wall and parotids; the mean effective dose was 0.017 mSv per MBq.
Bone lesions against sodium fluoride PET
In 15 men with metastatic prostate cancer scanned with both tracers within 24 hours, 96.5% of 405 bone lesions were clearly positive on 18F-DCFPyL against 95.8% on sodium fluoride PET; the PSMA scan also showed soft-tissue disease.
Hormone therapy did not blunt accuracy
In 93 OSPREY cohort B patients with biopsy results, median sensitivity was 96.4% in the 32 on concurrent hormone therapy and 95.4% in those not on it; positive predictive value was 90.0% against 77.4%.
Kidney cancer, an off-label use
In 14 patients with presumed oligometastatic clear cell renal cell carcinoma, the scan found 29 metastatic sites against 21 on conventional imaging, and three patients were no longer considered oligometastatic. This use is investigational.
First approval summary
Summarises the development of piflufolastat F 18 by Progenics, a Lantheus company, up to its US approval in May 2021 for PSMA PET in men with suspected metastasis before definitive therapy or suspected recurrence with rising PSA.
Dosing Data
Piflufolastat F 18 is a single intravenous diagnostic dose, measured in radioactivity and given by nuclear medicine staff; the PET scan starts about an hour later.
Educational information, not medical advice. Each dose above is tagged with its source: an approved label, a published human study, animal data, or amounts reported by users. None is a recommendation for you. An unapproved compound has no established safe or effective human dose, and products sold for “research use only” are not made or tested for people. Talk to a doctor before acting on anything on this site, including before you start, stop or change any medicine or dose. Full medical disclaimer.
What a Buyer Needs to Know
What is sold, how it is mixed, stored and taken, and what is known about its safety, quality and legal status. Each part names its source. Where we have none, it says unknown.
What is sold
The approved products, as their labels describe them:
- Pylarify (piflufolastat f-18 injection): PYLARIFY injection is supplied in a 50 mL multiple-dose glass vial containing a clear, colorless solution at a strength of 37 MBq/mL to 2,960 MBq/mL (1 mCi/mL to 80 mCi/mL) piflufolastat F 18 at calibration time and date.
- Pylarify Truvu (piflufolastat f-18 injection): PYLARIFY TRUVU (piflufolastat F 18) injection is supplied as 37 MBq/mL to 4,440 MBq/mL (1 mCi/mL to 120 mCi/mL) of piflufolastat F 18 in up to 55 mL at end of synthesis as a clear, colorless to pale yellow solution in a multiple-dose glass vial.
Source: Pylarify (piflufolastat f-18 injection) label, How Supplied (DailyMed version 11, effective February 18, 2026); Pylarify Truvu (piflufolastat f-18 injection) label, How Supplied (DailyMed version 5, effective July 1, 2026).
Mixing a vial: a worked example
Nothing to mix at home, and no syringe units to work out: Piflufolastat F 18 is a radioactive drug, prepared and given in nuclear-medicine departments, and its dose is an amount of radioactivity (MBq or GBq), not a weight.
This page's dosing note: “Piflufolastat F 18 is dosed by radioactivity, 296 to 370 MBq, measured by nuclear medicine staff against the time since production; no reconstitution maths applies.”
Its label says: “Only authorized persons qualified by training and experience should receive, use, and administer PYLARIFY.”
Source: this page's own note in Dosing Data below; Pylarify (piflufolastat f-18 injection) label, section 2 (DailyMed version 11, effective February 18, 2026); the amount of each dose row in Dosing Data below.
Storage before and after mixing
Unknown: the label on file for Piflufolastat F 18 (Pylarify (piflufolastat f-18 injection) label, sections 16 and 2 (DailyMed version 11, effective February 18, 2026)) has no storage sentence we could read. It is a radioactive drug held by the nuclear-medicine department that prepares and gives it (see the part above); the home rules for a mixed vial in the mixing guide do not apply to it.
How it is taken
As the approved label gives it: Intravenous bolus (Single injection; Label: PSMA PET in men with prostate cancer (Pylarify)).
Source: Manufacturer's recommended dosing (FDA label): the route and frequency of each row in Dosing Data below.
What to expect, and when
How long it stays in the body: not established by a measurement cited on this entry.
How long the doses were given: Label: PSMA PET in men with prostate cancer (Pylarify): Imaging about 60 minutes after injection, not later than 90 minutes; Label: PSMA PET in men with prostate cancer (Pylarify TruVu): Imaging about 60 minutes after injection.
When effects appear: unknown; no source on this page gives a time to effect for Piflufolastat F 18. Results reported in the studies are under Published Research.
Source: Manufacturer's recommended dosing (FDA label), the duration of each row in Dosing Data below.
Side effects, and when to stop or get help
From the Side Effects section: No drug-related or serious adverse events in the 205 men of the PYTHON trial; Radiation exposure: an effective dose of 0.017 mSv per MBq in the dosimetry study, with the highest doses to tear glands, salivary glands and kidneys. Full list and cautions ↓
When to stop or get help: unknown; the label's warnings summary we read gives no rule for stopping Piflufolastat F 18. Treat a severe or unexpected reaction as a reason to stop and see a doctor.
Source: the Side Effects section below (“From the studies above”).
Interactions
- androgen deprivation therapy and other therapies targeting the androgen pathway: may change piflufolastat F 18 uptake in prostate cancer
Every peptide's record, with its source: the interaction matrix.
Source: Pylarify (piflufolastat F 18) injection, US prescribing information, section 7. DailyMed set a00e5cbc, version 11, effective February 18, 2026, read October 28, 2026.
Checking what you bought
Unknown: no published independent test of Piflufolastat F 18 products is in our lab-results database yet, so how products sold under this name measure up is not known.
To read a certificate of analysis, paste it into the COA decoder; it checks the measured mass against Piflufolastat F 18's expected mass, 441.4 Da, from this entry's molecular data. Trust & Verification explains what independent testing can and cannot show.
Legal status
US: FDA Approved (FDA-approved: Pylarify, NDA 214793 (Progenics), approved May 26, 2021, and Pylarify TruVu, NDA 220089 (Aphelion), approved March 6, 2026 (Drugs@FDA via openFDA, read October 29, 2026). Sport: Not on the 2026 List.
Country by country ↓ · Regulatory tracker
Source: this entry's approval status and the WADA Prohibited List, as in Legal Status below.
Side Effects & Contraindications
Reported Side Effects
From the studies above.
Contraindications & Cautions
From the Pylarify US prescribing information (DailyMed set a00e5cbc, version 11, effective February 18, 2026), sections 4, 5 and 7.
Legal Status
Piflufolastat F 18 is an approved prescription diagnostic drug in the US and EU, made by licensed radiopharmacies and given in nuclear medicine departments.
Frequently Asked Questions
?What is a PSMA PET scan?
A scan in which a small amount of a radioactive molecule that binds PSMA is injected, and a PET scanner maps where it collects. Because most prostate cancer cells carry a lot of PSMA, the map shows where the cancer is, often where CT and bone scans see nothing.
?Can I buy piflufolastat?
No. It is a radioactive prescription diagnostic, made in a licensed facility on the day of use, lasting only hours, and injected by nuclear medicine staff for a scan. It has no use outside imaging.
?How does it differ from gozetotide (PSMA-11)?
Both bind PSMA. Gozetotide carries gallium-68 and is prepared from a kit; piflufolastat carries fluorine-18, made in a cyclotron, which lasts longer. In a small comparison it showed every lesion the gallium tracer did, plus a few more.
?How is the scan done?
Patients drink water, receive one injection of about 333 MBq into a vein, empty the bladder, and lie in the scanner about an hour after the injection, with arms above the head. The scan takes 12 to 40 minutes.
?What can it miss?
Small deposits. Before surgery it found only about four in ten men whose lymph nodes held cancer, so a negative scan does not rule cancer out, and a positive spot is not always cancer.
References
- [fda-pi] Pylarify (piflufolastat F 18) injection, US prescribing information, sections 1, 2, 4, 5, 7, 11 and 12.3 (Progenics Pharmaceuticals; DailyMed set a00e5cbc, version 11, effective February 18, 2026; read October 29, 2026).
- [fda-pi] Pylarify TruVu (piflufolastat F 18) injection, US prescribing information, sections 2 and 11 (Aphelion; DailyMed set 121c1cb8, version 5, effective July 1, 2026; read October 29, 2026).
- [other] PubChem CID 71532123, Piflufolastat (non-radioactive; synonym DCFPyL): formula C18H23FN4O8, molecular weight 442.4. Read October 28, 2026. https://pubchem.ncbi.nlm.nih.gov/compound/71532123
- [fda] US FDA, Drugs@FDA (openFDA): PYLARIFY, NDA 214793, original approval May 26, 2021; PYLARIFY TRUVU, NDA 220089, original approval March 6, 2026; marketing status prescription. Read October 29, 2026.
- [other] European Medicines Agency, medicines list (JSON report, downloaded October 28, 2026): Pylclari (piflufolastat (18F)): authorised, marketing authorisation date November 27, 2023.
- [clinical-trial] Morris MJ, et al. "Diagnostic Performance of (18)F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase III, Multicenter Study." Clin Cancer Res, 2021;27(13):3674-3682. PMID: 33622706.
- [clinical-trial] Pienta KJ, et al. "A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with (18)F-DCFPyL in Prostate Cancer Patients (OSPREY)." J Urol, 2021;206(1):52-61. PMID: 33634707.
- [clinical-trial] Oprea-Lager DE, et al. "[(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." Eur J Nucl Med Mol Imaging, 2023;50(11):3439-3451. PMID: 37341747.
- [clinical-trial] Luining WI, et al. "[(18)F]Fluciclovine PET/CT versus [(18)F]DCFPyL PET/CT in patients with biochemical recurrence of prostate cancer after robot-assisted radical prostatectomy: a prospective, single-center, single-arm, comparative imaging trial." Eur J Nucl Med Mol Imaging, 2026;53(7):4414-4423. PMID: 41762267.
- [pubmed] Metser U, et al. "Effect of (18)F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial." Radiology, 2022;303(2):414-422. PMID: 35076300.
- [review] Sadaghiani MS, et al. "Detection of Biochemically Recurrent Prostate Cancer with [(18)F]DCFPyL PET/CT: An Updated Systematic Review and Meta-Analysis with a Focus on Correlations with Serum Prostate-Specific Antigen Parameters." Tomography, 2023;9(4):1504-1514. PMID: 37624113.
- [clinical-trial] Jansen BHE, et al. "Pelvic lymph-node staging with (18)F-DCFPyL PET/CT prior to extended pelvic lymph-node dissection in primary prostate cancer - the SALT trial." Eur J Nucl Med Mol Imaging, 2021;48(2):509-520. PMID: 32789599.
- [clinical-trial] Nordquist LT, et al. "An intra-patient contemporaneous comparison of (18)F-piflufolastat and (18)F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy." Eur J Nucl Med Mol Imaging, 2026;53(6):3529-3541. PMID: 41729277.
- [pubmed] Dietlein M, et al. "Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer." Mol Imaging Biol, 2015;17(4):575-84. PMID: 26013479.
- [clinical-trial] Giesel FL, et al. "Intraindividual Comparison of (18)F-PSMA-1007 and (18)F-DCFPyL PET/CT in the Prospective Evaluation of Patients with Newly Diagnosed Prostate Carcinoma: A Pilot Study." J Nucl Med, 2018;59(7):1076-1080. PMID: 29269569.
- [pubmed] Plyku D, et al. "Combined model-based and patient-specific dosimetry for (18)F-DCFPyL, a PSMA-targeted PET agent." Eur J Nucl Med Mol Imaging, 2018;45(6):989-998. PMID: 29460025.
- [clinical-trial] Rowe SP, et al. "Prospective Comparison of PET Imaging with PSMA-Targeted (18)F-DCFPyL Versus Na(18)F for Bone Lesion Detection in Patients with Metastatic Prostate Cancer." J Nucl Med, 2020;61(2):183-188. PMID: 31451492.
- [clinical-trial] Saperstein L, et al. "Impact of Concomitant Hormone Therapy on the Diagnostic Performance of (18)F-Piflufolastat PET/CT in Prostate Cancer Patients: A Sub-Group Analysis of OSPREY Cohort B." Prostate, 2025;85(11):1005-1015. PMID: 40320701.
- [clinical-trial] Meyer AR, et al. "Improved identification of patients with oligometastatic clear cell renal cell carcinoma with PSMA-targeted (18)F-DCFPyL PET/CT." Ann Nucl Med, 2019;33(8):617-623. PMID: 31147927.
- [review] Keam SJ. "Piflufolastat F 18: Diagnostic First Approval." Mol Diagn Ther, 2021;25(5):647-656. PMID: 34292532.
Sources & Citations
Studies were read from their PubMed abstracts; the Pylarify and Pylarify TruVu labels from DailyMed and the approvals from Drugs@FDA and the EMA medicines list, read October 29, 2026. The stub's searches (October 28, 2026) found 484 PubMed records for piflufolastat or DCFPyL, 72 ClinicalTrials.gov studies, 2 Drugs@FDA records and 1 EMA record.
Medical Disclaimer: This content is for educational and informational purposes only. It is not medical advice, and nothing here is an instruction to obtain or use any compound. Talk to a licensed clinician about your own situation.