An Expert Monograph on Piflufolastat F 18: A Radiopharmaceutical Agent for Prostate Cancer Imaging

Executive Summary

Piflufolastat F 18 is a second-generation, small-molecule radiopharmaceutical designed for the diagnostic imaging of prostate cancer using Positron Emission Tomography (PET). As a high-affinity inhibitor of Prostate-Specific Membrane Antigen (PSMA), a protein significantly overexpressed in the vast majority of prostate cancer cells, Piflufolastat F 18 enables the precise visualization of PSMA-positive lesions throughout the body. Labeled with the positron-emitting radionuclide Fluorine-18, the agent offers logistical and imaging advantages over earlier-generation tracers, contributing to its rapid and widespread clinical adoption.

Regulatory approval has been granted by major health authorities, including the U.S. Food and Drug Administration (FDA) under the brand name Pylarify® and the European Medicines Agency (EMA) as Pylclari®. The approved indications encompass two critical clinical scenarios: the initial staging of men with high-risk prostate cancer who are candidates for definitive therapy, and the localization of disease in men with suspected cancer recurrence based on rising serum Prostate-Specific Antigen (PSA) levels.

The agent's efficacy and safety were established in two pivotal multicenter clinical trials, OSPREY and CONDOR. The OSPREY trial demonstrated an exceptionally high specificity (97.9%) and positive predictive value (86.7%) for detecting pelvic lymph node metastases in high-risk patients, establishing that a positive finding is a highly reliable indicator of disease. The CONDOR trial proved the agent's utility in biochemical recurrence, achieving a high Correct Localization Rate (84.8%-87.0%) in patients with non-informative conventional imaging, even at low PSA levels. Clinical utility studies have consistently shown that the enhanced detection capabilities of Piflufolastat F 18 PET/CT lead to changes in patient management in a substantial proportion of cases, underscoring its role as a transformative, decision-guiding tool.

Piflufolastat F 18 is well-tolerated, with a favorable safety profile characterized by infrequent and mild adverse reactions, primarily headache, dysgeusia, and fatigue. The use of the Fluorine-18 isotope, with its 110-minute half-life, facilitates centralized production and broad distribution, enhancing its accessibility. Piflufolastat F 18 has fundamentally altered the diagnostic paradigm for prostate cancer, shifting the standard from anatomical to molecular-based staging and providing clinicians with a superior modality for more accurate disease assessment and informed therapeutic planning.

Introduction: The Evolving Paradigm of Prostate Cancer Imaging

The Diagnostic Challenge

Prostate cancer remains the most prevalent non-cutaneous malignancy among men in North America, presenting a persistent and significant public health challenge.[1] A central difficulty in the management of this disease has long been the inadequate performance of conventional imaging modalities—namely computed tomography (CT) and magnetic resonance imaging (MRI)—in accurately staging the extent of disease at initial diagnosis and in localizing sites of recurrence.[3] These anatomical imaging techniques primarily rely on morphological criteria, such as lymph node size or the presence of sclerotic bone lesions, to infer the presence of metastases. However, metastatic deposits often exist at a microscopic level without causing discernible structural changes, leading to a high rate of false-negative findings and significant limitations in sensitivity.[5] This diagnostic gap is particularly pronounced in the setting of biochemical recurrence, where rising serum Prostate-Specific Antigen (PSA) levels indicate disease relapse, yet conventional imaging frequently fails to identify the location of the cancer, especially at low PSA concentrations.[5] This inability to accurately visualize the full disease burden can lead to suboptimal treatment decisions, such as performing local therapies that are futile in the presence of occult distant metastases.

The Rise of PSMA as a Biomarker

The limitations of anatomical imaging created a critical need for a more sensitive and specific method, driving the focus toward molecular imaging targets. Prostate-Specific Membrane Antigen (PSMA), also known as Glutamate carboxypeptidase 2, emerged as a nearly ideal biomarker for this purpose.[1] PSMA is a type II transmembrane glycoprotein whose expression in normal prostate tissue is approximately 1000-fold greater than in most other tissues in the body.[1] Crucially, its expression is further upregulated in prostate cancer, with the highest levels observed in metastatic and castration-resistant disease.[1] This profound differential expression between malignant prostate tissue and normal background tissue provides an exceptional target for high-contrast molecular imaging, allowing for the visualization of cancer cells with high fidelity.[5] Over 90% of primary and metastatic prostate cancers overexpress PSMA, making it a broadly applicable target across the disease spectrum.[5]

PET Imaging as a Solution

Positron Emission Tomography (PET) is a nuclear medicine imaging modality that detects the metabolic or molecular activity of cells rather than their anatomical structure. While PET images have lower spatial resolution compared to CT or MRI, their functional nature provides unparalleled sensitivity for detecting disease processes.[1] When a PET scan is performed with a radiopharmaceutical specifically designed to bind to a cancer-associated target like PSMA, it can reveal the location of cancerous tissue anywhere in the body, provided the cells express the target protein.[1] The development of PSMA-targeted PET agents, therefore, represents a fundamental shift in the staging of prostate cancer. This transition moves beyond the late and often unreliable anatomical signs of metastasis toward the direct detection of the cancer's biological signature. This molecular approach enables the identification of disease at a much earlier and smaller scale, effectively redefining what constitutes "metastatic disease" and challenging traditional treatment paradigms that were established based on the limitations of older, less sensitive imaging technologies. This ability to reveal a previously invisible disease burden is the primary reason that PSMA-PET imaging, with agents like Piflufolastat F 18, so frequently leads to significant changes in patient management.[7]

Piflufolastat F 18: Chemical, Physical, and Radiopharmaceutical Profile

Chemical Identity

Piflufolastat F 18 is a small-molecule, urea-based diagnostic agent specifically engineered to target PSMA.[1] Its systematic chemical name is (2S)-2-pentyl]carbamoylamino]pentanedioic acid.[2] The molecule is most commonly referred to in scientific literature by its developmental name, [18F]-DCFPyL, with other synonyms including 18F-DCFPyL and PyL.[1] Its chemical formula is

C18​H23​[18F]N4​O8​, and it has a molar mass of approximately 441.4 g/mol.[11]

A summary of its key identifiers and properties is provided in Table 1, consolidating data from multiple sources into a single reference.

Table 1: Key Identifiers and Properties of Piflufolastat F 18

Identifier Type	Value	Source Snippet(s)
Generic Name	Piflufolastat F 18	1
English Name	Piflufolastat F 18	User Query
DrugBank ID	DB14805	1
Type	Small Molecule	1
CAS Number	1207181-29-0	2
UNII	3934EF02T7	2
Chemical Formula	C18​H23​[18F]N4​O8​	11
Molar Mass	441.4 g/mol	11
Key Synonyms	[F-18]-DCFPyL, 18F-DCFPyL, PyL	1

Radiochemical Synthesis

The synthesis of Piflufolastat F 18 is a sophisticated, multi-step process dictated by the short physical half-life of the Fluorine-18 radionuclide (approximately 109.8 minutes).[12] This short half-life necessitates that the final radiolabeled product be synthesized at or near the clinical site on the day of administration.

1. Production of Fluorine-18: The process begins in a medical cyclotron, a particle accelerator that bombards a target of enriched Oxygen-18 water (H218​O) with high-energy protons.[14] This induces the 18O(p,n)18F nuclear reaction, which transmutes Oxygen-18 into Fluorine-18, yielding aqueous [18F]fluoride ions.[14] The [18F]fluoride is then separated and purified, typically using anion exchange chromatography, to prepare it for the labeling reaction.[14]
2. Precursor Synthesis: Concurrently, a non-radioactive precursor molecule is synthesized through conventional organic chemistry. For Piflufolastat F 18, this precursor is a trimethylammonium salt, which is assembled in a convergent fashion from starting materials such as Di-t-butyl glutamate hydrochloride and 6-chloronicotinic acid.[12] This precursor is designed with a specific leaving group (the trimethylammonium group) that can be efficiently displaced by the [18F]fluoride in the final step. The other reactive functional groups on the molecule are protected, typically as tert-butyl esters, to prevent side reactions.[12]
3. Automated Radiosynthesis and Purification: The final and most time-critical step is performed in a shielded "hot cell" using a fully automated synthesis module, such as a GE TRACERlab or Sofie Biosciences ELIXYS system.[15] The purified [18F]fluoride is activated, and then reacted with the precursor molecule. This triggers a direct nucleophilic heteroaromatic substitution, where the [18F]fluoride ion displaces the trimethylammonium leaving group to form the carbon-fluorine bond.[12] Following this radiolabeling step, the tert-butyl ester protecting groups are removed under acidic conditions (deprotection). The crude product is then purified using High-Performance Liquid Chromatography (HPLC) to remove unreacted precursors and byproducts.[12] The final product is formulated in a sterile, injectable solution. The entire automated process, from labeling to final formulation, is completed within 55 to 90 minutes, with reported decay-corrected radiochemical yields typically ranging from 19% to 31%.[12]

The selection of Fluorine-18 as the radionuclide is a strategic one that directly influences the agent's clinical utility and accessibility. While Gallium-68 (68Ga), another common PET isotope, can be produced on-site with a relatively simple generator, its shorter half-life (68 minutes) and lower production yield limit its distribution to the immediate vicinity of the generator.[18] In contrast, the longer half-life of 18F and the ability of cyclotrons to produce it in large quantities enable a centralized manufacturing model. A single radiopharmacy can produce large batches of Piflufolastat F 18 and distribute it to multiple hospitals and imaging centers within a several-hour radius.[5] This logistical advantage was a key factor in the rapid and broad commercial availability of Pylarify® across the United States following its approval, a significant differentiator from the first-approved 68Ga-based agent, which was initially limited to only two production sites.[5]

Preclinical Profile: Mechanism of Action and Pharmacokinetics

Mechanism of Action

The mechanism of action of Piflufolastat F 18 is predicated on its high binding affinity and specificity for Prostate-Specific Membrane Antigen (PSMA), which is also identified as Glutamate carboxypeptidase 2.[1] Following intravenous administration, the Piflufolastat F 18 molecule circulates throughout the body and binds to the extracellular domain of the PSMA protein, which is abundantly expressed on the surface of prostate cancer cells.[2]

Once bound, the molecule is internalized by the cancer cell via clathrin-mediated endocytosis, leading to an accumulation of the radiotracer within the tumor.[23] The Fluorine-18 atom attached to the molecule is an unstable radionuclide that decays via positron (

β+) emission.[21] A positron is an anti-electron that, upon being emitted, travels a very short distance within the tissue before it encounters an electron. This encounter results in an annihilation event, converting the mass of both particles into two high-energy (511 keV) gamma photons that are emitted in opposite directions (

 180° apart).[21] The PET scanner is designed with a ring of detectors that simultaneously register these pairs of photons. By analyzing the timing and location of millions of these coincidence events, a computer algorithm can reconstruct a three-dimensional image that maps the concentration and location of the radiotracer within the body, thereby revealing the sites of PSMA-positive prostate cancer.[21]

Pharmacokinetics and Biodistribution

The pharmacokinetic profile of Piflufolastat F 18 describes its movement into, through, and out of the body, which is critical for determining the optimal imaging time and understanding its pattern of physiological uptake.

• Distribution: After intravenous injection, Piflufolastat F 18 is rapidly cleared from the blood and distributed to tissues. The blood concentration declines in a biphasic manner, with a rapid initial distribution phase characterized by a half-life of approximately 0.17 hours (10.2 minutes).[1] Within 60 minutes, significant physiological uptake is observed in organs known to have high PSMA expression or that are involved in its clearance. These include the kidneys (which receive approximately 16.5% of the administered activity), the liver (9.3%), and the spleen, as well as the lacrimal and salivary glands.[1] This biodistribution pattern is important for image interpretation, as high uptake in these normal organs constitutes the expected background.
• Elimination: The primary route of elimination for Piflufolastat F 18 is renal. The agent is excreted via the urine, with approximately 50% of the administered radioactive dose being eliminated within the first 8 hours after injection.[1] The slower, terminal elimination phase is characterized by a half-life of approximately 3.47 hours.[1]
• Metabolism: The provided source materials do not contain information regarding the metabolism of Piflufolastat F 18.[1]

The key pharmacokinetic parameters are summarized in Table 2.

Table 2: Summary of Pharmacokinetic Parameters

Parameter	Value	Source Snippet(s)
Distribution Half-Life	0.17±0.044 hours	1
Elimination Half-Life	3.47±0.49 hours	1
Route of Elimination	Urinary Excretion	1
% Excreted in Urine (8h)	~50%	1
Key Organs of Uptake (% Administered Activity at 60 min)	Kidneys (16.5%), Liver (9.3%), Lung (2.9%)	1

Regulatory and Commercial Landscape

Regulatory Approvals

Piflufolastat F 18 has successfully navigated the rigorous regulatory pathways in both the United States and the European Union, securing approvals that have made it a standard-of-care imaging agent.

• U.S. Food and Drug Administration (FDA): The FDA approved Piflufolastat F 18 on May 27, 2021, under the brand name Pylarify®.[1] It was the second PSMA-targeted PET agent to receive FDA approval, following Ga 68 PSMA-11, but was the first to be made widely and commercially available across the nation, a key distinction that facilitated its rapid adoption.[5]
• European Medicines Agency (EMA): The EMA granted marketing authorization for Piflufolastat F 18 on July 28, 2023, under the brand name Pylclari®.[1]

Approved Indications

The indications for use are highly concordant between the two regulatory bodies, focusing on critical decision points in the management of prostate cancer.

• FDA (Pylarify®): The agent is indicated for positron emission tomography (PET) of PSMA-positive lesions in men with prostate cancer in two specific settings:

1. For patients with suspected metastasis who are candidates for initial definitive therapy (i.e., initial staging of high-risk disease).
2. For patients with suspected recurrence based on an elevated serum PSA level (i.e., biochemical recurrence).[1]

• EMA (Pylclari®): The indications are similarly defined:

1. For the primary staging of patients with high-risk prostate cancer prior to initial curative therapy.
2. For localizing the recurrence of prostate cancer in patients with a suspected recurrence based on increasing serum PSA levels after primary treatment with curative intent.[1]

Commercialization and Manufacturing

The global commercialization of Piflufolastat F 18 is managed through a strategic partnership, resulting in different brand names and marketing entities in the U.S. and Europe.

• United States: Pylarify® is developed and marketed by Lantheus Holdings, Inc., through its subsidiary Progenics Pharmaceuticals, Inc..[25] Following its approval, Pylarify® quickly became the most utilized PSMA PET agent in the U.S. market, a testament to its clinical utility and the logistical advantages of its F-18 label.[30]
• Europe: The European rights for the agent were licensed to Curium by Progenics/Lantheus in 2018.[30] Curium markets the product as Pylclari® and is responsible for its manufacturing and distribution across Europe. Following the 2023 EMA approval, Curium has been progressively launching the product in various countries, including Austria, France, Germany, Greece, Italy, the Netherlands, Spain, and the Nordic nations.[30]

The more than two-year gap between the FDA and EMA approvals illustrates the distinct timelines and requirements of different global regulatory bodies. The dual-brand strategy (Pylarify® in the U.S., Pylclari® in the E.U.) managed by separate corporate partners (Lantheus and Curium, respectively) is a common and effective approach in the radiopharmaceutical industry. It allows a developer to leverage a partner's established regional expertise in manufacturing, navigating local reimbursement landscapes, and marketing to nuclear medicine facilities, thereby accelerating patient access in different territories.[30]

Analysis of Pivotal Clinical Evidence

The regulatory approvals of Piflufolastat F 18 were based on a robust clinical development program, highlighted by two pivotal, prospective, multicenter trials: OSPREY and CONDOR. These studies were designed to rigorously evaluate the diagnostic performance of the agent across the prostate cancer disease continuum.

6.1. The OSPREY Trial (NCT02981368): Staging High-Risk and Recurrent Disease

The OSPREY trial was a Phase 2/3 study that assessed the diagnostic accuracy of Piflufolastat F 18 PET/CT against a histopathological "gold standard".[5] The trial enrolled two distinct cohorts to evaluate the agent in different clinical settings.

• Trial Design:
• Cohort A: Included 252 evaluable men with newly diagnosed, high-risk prostate cancer as defined by NCCN criteria. All patients in this cohort were scheduled to undergo radical prostatectomy with extended pelvic lymph node dissection (RP-PLND), which provided the tissue for histopathological truth.[37]
• Cohort B: Included 93 evaluable men who had radiologically suspected recurrent or metastatic prostate cancer based on conventional imaging. In this cohort, suspicious lesions identified on the PET scan were biopsied to confirm the presence of prostate cancer.[37]
• Analysis of Cohort A (Initial Staging): The co-primary endpoints for this cohort were the sensitivity and specificity of the PET scan for detecting pelvic lymph node metastases at the patient level. The results, summarized in Table 3, revealed a nuanced performance profile.
• Specificity: The trial successfully met its pre-specified endpoint for specificity. Across three independent, blinded readers, the median specificity was 97.9% (95% CI: 94.5%–99.4%).[36] This exceptionally high specificity indicates a very low false-positive rate, meaning that a pelvic lymph node identified as positive on a Piflufolastat F 18 scan is highly likely to contain metastatic cancer.
• Sensitivity: The trial did not meet its co-primary endpoint for sensitivity. The median sensitivity was 40.3% (95% CI: 28.1%–52.5%), which fell below the pre-specified success threshold.[36] This moderate sensitivity suggests that the scan is unable to detect a substantial portion of true pelvic nodal disease, a limitation attributed to the inherent resolution limits of PET technology in identifying very small micrometastatic deposits.
• Predictive Values: Consistent with the sensitivity and specificity findings, the median Positive Predictive Value (PPV) was high at 86.7%, while the Negative Predictive Value (NPV) was moderate at 83.2%.[37]

Table 3: Diagnostic Performance in the OSPREY Trial (Patient-Level, Pelvic Nodal Involvement, Cohort A)

Metric	Median Value (3 Readers)	95% Confidence Interval	Endpoint Met?
Specificity	97.9%	94.5%–99.4%	Yes
Sensitivity	40.3%	28.1%–52.5%	No
Positive Predictive Value (PPV)	86.7%	69.7%–95.3%	N/A
Negative Predictive Value (NPV)	83.2%	78.2%–88.1%	N/A

The statistical performance demonstrated in OSPREY Cohort A has direct and critical clinical implications. The combination of very high specificity with moderate sensitivity defines Piflufolastat F 18 as a powerful "rule-in" test, but an unreliable "rule-out" test for pelvic nodal disease. If the scan identifies a suspicious pelvic lymph node, the high specificity and PPV provide a strong rationale to alter treatment, for example, by adding pelvic radiation to a planned prostate-only radiation field. However, the moderate sensitivity and NPV mean that a negative scan of the pelvis cannot be used to de-escalate therapy. A surgeon, for instance, cannot confidently omit a planned pelvic lymph node dissection based solely on a negative Piflufolastat F 18 scan, as there remains a significant probability that microscopic disease is present but was not detected.[36] This understanding is paramount to prevent the undertreatment of patients with high-risk disease.

• Analysis of Cohort B (Recurrent/Metastatic Disease): In this cohort, where patients already had suspected metastatic disease, the scan demonstrated excellent performance in confirming and localizing extraprostatic lesions. The median sensitivity was 95.8% (95% CI: 87.8%–99.0%), and the median PPV was 81.9% (95% CI: 73.7%–90.2%).[36] These results validate the agent's ability to reliably detect sites of disease in patients with known or suspected metastases.

6.2. The CONDOR Trial (NCT03739684): Detecting Biochemical Recurrence

The CONDOR trial was a Phase 3 study specifically designed to evaluate Piflufolastat F 18 in one of the most challenging clinical scenarios: biochemical recurrence with non-informative conventional imaging.[5]

• Trial Design: The study enrolled 208 men who had rising PSA levels after definitive therapy but whose standard CT, MRI, and/or bone scans were either negative or equivocal for metastatic disease.[6]
• Primary Endpoint: The primary endpoint was the Correct Localization Rate (CLR), a stringent measure defined as the percentage of patients where at least one lesion identified on the PET scan was confirmed as true disease by a composite standard of truth (histopathology, correlative follow-up imaging, or PSA response to targeted radiation).[43]
• Results: The trial successfully achieved its primary endpoint. The CLR, as determined by three blinded readers, was high, ranging from 84.8% to 87.0%.[9] This result unequivocally demonstrated the agent's ability to correctly identify the location of recurrent disease when conventional imaging fails. Key efficacy endpoints are summarized in Table 4.
• Performance at Low PSA: The agent's utility was confirmed even in patients with very low PSA levels, a group where conventional imaging is notoriously insensitive. A sub-analysis of patients with PSA levels below 0.5 ng/mL found that the scan still provided actionable information that led to a change in management for 39.1% of them.[9] Another sub-analysis focused on the prostate/prostatic bed and found a high PPV (ranging from 75% to 100% across readers) even in this low-PSA subgroup, providing confidence in scan findings of local recurrence.[44]
• Detection Rate: The overall disease detection rate, defined as the percentage of patients in whom the scan identified at least one suspicious lesion, was between 59% and 66%.[6]

Table 4: Key Efficacy Endpoints from the CONDOR Trial

Metric	Result Range (3 Readers)	95% CI Lower Bound
Correct Localization Rate (CLR)	84.8% - 87.0%	77.8% - 80.4%
Overall Disease Detection Rate	59% - 66%	N/A
PPV in Prostate Bed (PSA <0.5 ng/mL)	75% - 100%	N/A

6.3. Impact on Clinical Decision-Making and Patient Management

The ultimate measure of a diagnostic test's value is its ability to provide new, actionable information that improves patient care. Multiple studies have demonstrated that Piflufolastat F 18 PET/CT has a substantial impact on clinical decision-making.

• A retrospective analysis of 236 patients who received a Piflufolastat F 18 scan found that the results led to a change in the intended treatment plan for 54.5% of patients undergoing initial staging of high-risk disease and for 40% of patients being evaluated for biochemical recurrence.[7]
• Data from the CONDOR trial itself showed that the scan findings prompted a change in the intended management plan for nearly two-thirds of the enrolled patients, a population in whom previous imaging was uninformative.[9]
• These management changes are often significant, including escalating therapy from local to systemic approaches (e.g., adding androgen deprivation therapy) when previously undetected distant metastases are found, or altering radiation fields to target newly identified lesions.[9]

Piflufolastat F 18 is therefore not merely a tool for creating a better image; it functions as a critical decision-making instrument that re-stratifies patient risk and directly alters therapeutic strategies. By upstaging patients from clinically localized to metastatic disease, it helps avoid futile local treatments and guides them toward more appropriate systemic therapies. Conversely, by precisely identifying oligometastatic sites of recurrence, it opens the door for metastasis-directed therapies, such as stereotactic body radiation therapy, which were previously not possible without a clear target. This direct, causal link from superior detection to altered management is the central pillar of the agent's clinical utility.

Clinical Practice: Administration, Imaging, and Interpretation

The clinical use of Piflufolastat F 18 requires adherence to standardized protocols for patient preparation, dose administration, radiation safety, and image acquisition and interpretation to ensure optimal diagnostic quality and safety.

Patient Preparation

Proper patient preparation is straightforward but important. Patients should be well-hydrated before, during, and after the administration of the radiopharmaceutical. There are no fasting requirements. To minimize interference from radioactive urine in the pelvic region, patients are instructed to void immediately before the PET scan begins.[24]

Dosage and Administration

• Recommended Dose: The standard recommended dose is 333 MBq (9 mCi), with an acceptable administration range of 296 MBq to 370 MBq (8 mCi to 10 mCi).[5]
• Administration: The dose is administered as a single, slow bolus intravenous injection. To ensure the full dose is delivered, the injection should be followed by an intravenous flush with sterile 0.9% Sodium Chloride Injection, USP.[21]
• Handling: As a radioactive drug, Piflufolastat F 18 must be handled using aseptic technique and with appropriate radiation shielding, including syringe shields and waterproof gloves, by personnel qualified and authorized to handle radiopharmaceuticals.[21]

Radiation Safety

The ALARA ("As Low As Reasonably Achievable") principle is fundamental to the use of any radiopharmaceutical. All procedures should be designed to minimize radiation exposure to the patient, healthcare workers, and the general public.[21] The estimated effective radiation dose to an adult patient from a 370 MBq (10 mCi) injection is 4.3 mSv. The organs receiving the highest absorbed doses are the critical organs of clearance and uptake: the kidneys, liver, and spleen.[21] To reduce the radiation dose, particularly to the bladder wall, patients are strongly advised to maintain good hydration and to void frequently for the first few hours after the injection.[24]

Imaging Protocol

• Uptake Time: PET image acquisition should commence approximately 60 minutes after the intravenous injection of Piflufolastat F 18. This allows sufficient time for the agent to clear from the bloodstream and accumulate in PSMA-expressing tissues. Initiating the scan more than 90 minutes after injection is not recommended as it may adversely affect imaging performance.[21]
• Scan Area: The patient is typically positioned supine with arms raised above the head. The scan is acquired from the mid-thigh to the top of the skull to provide a whole-body survey for metastatic disease.[21]

Image Interpretation

Accurate interpretation of Piflufolastat F 18 PET/CT scans requires specialized training and a thorough understanding of the agent's biodistribution and potential pitfalls.

• Positive Findings: A lesion is generally considered suspicious for prostate cancer if its radiotracer uptake is focally increased above the surrounding background tissue where no physiological uptake is expected.[21]
• Pitfalls and False Positives: It is critically important to recognize that PSMA expression is not entirely specific to prostate cancer. Physiological uptake is normally seen in the lacrimal and salivary glands, liver, spleen, kidneys, and small intestine.[24] Furthermore, increased uptake can be observed in a variety of other conditions, both malignant (e.g., renal cell carcinoma, glioblastoma) and benign (e.g., fibrous dysplasia, Paget's disease of bone, fractures, infection, sarcoidosis).[6] One of the most common interpretation challenges is distinguishing pelvic lymph nodes from excreted radiotracer activity in the ureters, which can sometimes require delayed imaging or administration of a diuretic.[36]
• Clinical Correlation: Due to these potential confounders, image interpretation must always be performed in the context of the patient's full clinical history. A positive scan does not, in isolation, confirm the presence of metastatic prostate cancer, and a negative scan does not definitively rule it out. Clinical correlation, which may include comparison with other imaging modalities or histopathological evaluation of a suspicious site, is strongly recommended, especially when a scan finding would lead to a major change in therapy.[6]

Comprehensive Safety and Tolerability Profile

The safety of Piflufolastat F 18 has been well-established through its pivotal clinical trials, which included several hundred patients, and post-marketing experience. The agent is generally well-tolerated with a favorable safety profile.

Adverse Reactions

Adverse reactions associated with Piflufolastat F 18 are typically mild and infrequent.

• Common Reactions: The most frequently reported adverse events in the pivotal OSPREY and CONDOR trials, each occurring in 2% or less of patients, were headache, dysgeusia (an alteration in the sense of taste), and fatigue.[5]
• Uncommon and Other Reactions: A more extensive list of adverse events, derived from both clinical trials and post-marketing reports, is available from the European Medicines Agency. These include uncommon (affecting up to 1 in 100 people) events such as dizziness, rash, hypersensitivity, and injection site pain, as well as events of unknown frequency like syncope and nausea.[24] A summary of reported adverse reactions is provided in Table 5.

Table 5: Summary of Reported Adverse Reactions

Adverse Reaction	Incidence Rate	Source Snippet(s)
Headache	Common (≤2%)	11
Dysgeusia (Altered Taste)	Common (≤2%)	11
Fatigue	Common (≤2%)	5
Hypersensitivity	Uncommon (0.2%)	5
Dizziness	Uncommon	24
Rash	Uncommon	24
Injection Site Pain	Uncommon	24
Syncope (Fainting)	Not Known	24
Nausea	Not Known	24

Contraindications

The U.S. Prescribing Information for Pylarify® lists no contraindications.[21] The Summary of Product Characteristics for Pylclari® in Europe lists hypersensitivity to the active substance or any of the excipients as a contraindication.[24]

Warnings and Precautions

• Risk of Image Misinterpretation: As previously detailed, PSMA uptake is not specific for prostate cancer. Interpreting physicians must be aware of the potential for false-positive and false-negative findings. The diagnostic performance of the scan can be influenced by clinical factors such as the patient's serum PSA level and tumor Gleason score.[6]
• Hypersensitivity Reactions: Although rare, serious allergic reactions are possible. A delayed hypersensitivity reaction was reported in one patient (0.2%) in the clinical trial program who had a history of other allergies.[5] Facilities administering Piflufolastat F 18 should be prepared to manage such reactions, with trained staff and resuscitation equipment readily available.[6]
• Radiation Risks: The administration of any radiopharmaceutical, including Piflufolastat F 18, exposes the patient to ionizing radiation. This exposure is associated with a long-term, dose-dependent increased risk of cancer. The benefit of the diagnostic information obtained from the scan must be weighed against this risk for each patient. Adherence to radiation safety protocols is essential to protect both patients and healthcare personnel.[21]

Drug Interactions

The concomitant use of androgen deprivation therapy (ADT) or other drugs that target the androgen receptor pathway (e.g., enzalutamide, apalutamide) may result in changes in PSMA expression on prostate cancer cells. This could, in turn, alter the uptake of Piflufolastat F 18. The precise effect of these therapies on the diagnostic performance of the PET scan has not been formally established and should be considered during image interpretation.[22]

Comparative Analysis: 18F-Piflufolastat versus 68Ga-PSMA-11

In the landscape of PSMA-targeted PET imaging, Piflufolastat F 18 ([18F]DCFPyL) and Gallium-68 PSMA-11 ([68Ga]Ga-PSMA-11) are the two most established and widely used agents. While both are highly effective and target the same molecular entity, they possess distinct characteristics related to their radionuclide, production, and imaging properties. A detailed comparison is essential for understanding their respective roles in clinical practice.

The choice between these two leading agents is rarely a matter of clear clinical superiority for all cases. Instead, it represents a pragmatic decision based on a multifactorial assessment of institutional infrastructure, logistical feasibility, cost, and specific clinical questions. The evidence does not support a universal preference for one agent's diagnostic accuracy over the other in the majority of clinical scenarios.[18] Therefore, practical considerations often become the deciding factors. A large academic center with its own cyclotron may leverage the advantages of Fluorine-18 to produce large, economical batches for its main campus and satellite imaging centers. A smaller or more remote hospital may find the smaller footprint and simpler on-site production of a Gallium-68 generator to be more practical and cost-effective. The clinical context can also influence the choice; for instance, while both Piflufolastat F 18 and Ga-68 PSMA-11 have similar renal excretion, a different F-18 agent with lower urinary activity might be theoretically preferred for evaluating a suspected recurrence immediately adjacent to the bladder.[18] Ultimately, the availability of these highly effective tools has expanded access to high-quality PSMA-PET imaging, with local factors often guiding the selection process.

Table 6: Comparative Profile of Piflufolastat F 18 vs. Gallium-68 PSMA-11

Feature	Piflufolastat F 18 ([18F]DCFPyL)	Gallium-68 PSMA-11 ([68Ga]Ga-PSMA-11)	Clinical Implication/Insight
Radionuclide	Fluorine-18 (18F)	Gallium-68 (68Ga)	Different physical properties lead to differences in imaging and logistics.
Half-Life	~110 minutes	~68 minutes	The longer half-life of 18F allows for centralized manufacturing, longer transport times, and more flexible patient scheduling.5
Production Method	Cyclotron	68Ge/68Ga Generator	Cyclotron production is complex but allows for large-scale, high-yield batches. Generator production is simpler and has a smaller footprint but produces smaller batches.18
Availability/Logistics	High; suitable for "hub-and-spoke" distribution model.	More limited; typically requires an on-site generator, restricting distribution range.6	Piflufolastat F 18 has broader commercial availability in many regions due to its production logistics.
Image Resolution	Theoretically higher due to lower positron energy and shorter positron range of 18F.18	Standard resolution for PET imaging.	Higher resolution of 18F may aid in the detection of smaller lesions, though clinical impact versus 68Ga is debated.
Lesion SUVmax	Generally reported to be higher than with 68Ga agents.18	Generally lower than 18F agents.	Higher SUV may provide greater image contrast and more confident lesion detection, but does not necessarily translate to a higher detection rate.
Benign Bone Uptake	Can show uptake in benign bone lesions (e.g., fractures, fibrous dysplasia).36	Some studies suggest lower non-specific uptake in benign bone lesions compared to 18F agents.18	Lower benign bone uptake with 68Ga may potentially reduce the rate of false-positive findings in the skeleton.
Urinary Excretion	High; primary route of elimination is renal.1	High; primary route of elimination is renal.54	High urinary activity can obscure lesions in the prostate bed or pelvic lymph nodes near the bladder for both agents.
Overall Clinical Performance	High diagnostic accuracy; meta-analyses show similar lesion detection rates to 68Ga-PSMA-11.19	High diagnostic accuracy; considered a benchmark PSMA agent. Most studies show broad equivalence to Piflufolastat F 18.18	Both agents are considered excellent and largely interchangeable for most clinical indications. The choice is often driven by availability and logistics.

Future Directions and Ongoing Investigations

While Piflufolastat F 18 is firmly established as a leading diagnostic agent, its clinical utility continues to be explored in ongoing clinical trials, pushing its application beyond standard diagnosis and into the realm of treatment guidance and personalized medicine.

• Guidance for Targeted Therapies: The ability of Piflufolastat F 18 to precisely map the location of disease is being leveraged to guide focal therapies. A recruiting Phase 0 trial (NCT03861676) is investigating its use for image-guided focal brachytherapy, aiming to deliver radiation more accurately to cancerous lesions while sparing surrounding healthy tissue.[56]
• Role in Advanced Disease and Theranostics: In the setting of metastatic castration-resistant prostate cancer (mCRPC), Piflufolastat F 18 is being studied as a tool to assess patient eligibility for and response to PSMA-targeted radionuclide therapy. A Phase 4 trial (NCT06099093) is specifically evaluating its role in patients receiving Lutetium-177 vipivotide tetraxetan (Pluvicto™), a PSMA-targeted therapeutic agent.[57] This pairing of a diagnostic (Piflufolastat F 18) and a therapeutic (177Lu-PSMA) that both target PSMA is the essence of theranostics.
• Integration with Novel Therapeutics: The agent's role as a biomarker is expanding to novel drug classes. A Phase 1 trial (NCT06085664) is incorporating Piflufolastat F 18 imaging into a pre-surgical study of REGN5678, an innovative anti-PSMA x CD28 T-cell engaging bispecific antibody, likely to assess baseline PSMA expression and monitor treatment response.[58]

These ongoing investigations signal a clear evolution in the role of Piflufolastat F 18. Initially developed to "find" prostate cancer more effectively than previous methods, its application is now shifting toward helping to "fight" the disease with greater precision. Using the PET scan to guide focal radiation, select patients for PSMA-targeted theranostics, and potentially serve as a predictive biomarker for novel immunotherapies represents the next frontier for PSMA imaging, positioning Piflufolastat F 18 as a key tool in the advancement of personalized oncology.

Conclusion and Expert Recommendations

Piflufolastat F 18 represents a paradigm shift in the diagnostic imaging of prostate cancer. As a highly specific, second-generation PSMA-targeted PET agent, it has demonstrated unequivocal superiority over conventional anatomical imaging modalities in both the initial staging of high-risk disease and the detection of biochemical recurrence. The robust evidence from the pivotal OSPREY and CONDOR trials has established its clinical utility, showing that its high specificity and positive predictive value provide clinicians with a high degree of confidence in positive findings. This enhanced diagnostic accuracy translates directly into improved patient care, as the information provided by Piflufolastat F 18 PET/CT frequently and significantly alters clinical management decisions.

Based on the comprehensive analysis of the available evidence, the following expert recommendations are provided for the clinical use of Piflufolastat F 18:

1. Standard of Care: Piflufolastat F 18 PET/CT should be considered a standard-of-care imaging modality for the initial staging of men with high-risk localized or locally advanced prostate cancer and for the localization of disease in men with suspected biochemical recurrence following definitive therapy.
2. Interpretation Nuances: Clinicians must recognize the specific performance characteristics of the agent. Its very high specificity makes it an excellent "rule-in" test for metastatic disease. However, its moderate sensitivity for small-volume pelvic nodal disease means it is not a reliable "rule-out" test. Therefore, a negative pelvic scan in a high-risk patient should not be used as the sole justification to omit a planned pelvic lymph node dissection.
3. Specialized Interpretation: The interpretation of Piflufolastat F 18 PET/CT scans requires specialized training and a thorough understanding of its normal biodistribution, as well as the spectrum of potential benign and malignant false-positive findings. Clinical and/or pathological correlation should be strongly considered whenever a scan finding is equivocal or would substantially alter a major therapeutic decision.
4. Agent Selection: The choice between Piflufolastat F 18 and Gallium-68-based PSMA agents should be guided primarily by local availability, institutional logistics, and cost considerations. For the majority of clinical indications, the diagnostic performance of these agents is considered broadly equivalent.

In conclusion, Piflufolastat F 18 has fundamentally advanced the field of prostate cancer imaging, enabling more accurate staging, earlier detection of recurrence, and more informed, personalized treatment planning. Its continued investigation in the context of theranostics and novel therapeutics promises to further expand its role as an indispensable tool in modern oncology.

Works cited

1. Piflufolastat F 18: Uses, Interactions, Mechanism of Action | DrugBank Online, accessed August 25, 2025, https://go.drugbank.com/drugs/DB14805
2. Piflufolastat F-18 | C18H23FN4O8 | CID 52950901 - PubChem, accessed August 25, 2025, https://pubchem.ncbi.nlm.nih.gov/compound/Piflufolastat-F-18
3. Piflufolastat F-18 (>18>F-DCFPyL) for PSMA PET imaging in prostate cancer, accessed August 25, 2025, https://pure.johnshopkins.edu/en/publications/piflufolastat-f-18-sup18supf-dcfpyl-for-psma-pet-imaging-in-prost
4. Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer - PubMed, accessed August 25, 2025, https://pubmed.ncbi.nlm.nih.gov/35603510/
5. FDA Approves Piflufolastat F-18 Injection, a PSMA PET Imaging Agent, for the Detection of Metastatic or Recurrent Prostate Cancer - The ASCO Post, accessed August 25, 2025, https://ascopost.com/issues/june-10-2021/fda-approves-piflufolastat-f-18-injection-for-the-detection-of-metastatic-or-recurrent-prostate-cancer/
6. FDA approves second PSMA-targeted PET imaging drug for men with prostate cancer, accessed August 25, 2025, https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-second-psma-targeted-pet-imaging-drug-men-prostate-cancer
7. The impact of F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states. - ASCO Publications, accessed August 25, 2025, https://ascopubs.org/doi/10.1200/JCO.2023.41.6_suppl.63
8. Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review - PubMed, accessed August 25, 2025, https://pubmed.ncbi.nlm.nih.gov/36999911/
9. Role of Piflufolastat F 18 Reinforced in Prostate Cancer With Low PSA Levels, accessed August 25, 2025, https://www.targetedonc.com/view/role-of-piflufolastat-f-18-reinforced-in-prostate-cancer-with-low-psa-levels
10. Piflufolastat F18 - Curium Pharma/Progenics Pharmaceuticals - AdisInsight - Springer, accessed August 25, 2025, https://adisinsight.springer.com/drugs/800043091
11. Piflufolastat (18F) - Wikipedia, accessed August 25, 2025, https://en.wikipedia.org/wiki/Piflufolastat_(18F)
12. How is Piflufolastat F-18 synthesised?_Chemicalbook, accessed August 25, 2025, https://www.chemicalbook.com/article/how-is-piflufolastat-f-18-synthesised.htm
13. Fluorine-18 Radiochemistry, Labeling Strategies and Synthetic Routes - PMC, accessed August 25, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC4306521/
14. Synthesis of Fluorine-18 for Advanced PET Imaging - Open MedScience, accessed August 25, 2025, https://openmedscience.com/synthesis-of-fluorine-18-for-advanced-pet-imaging/
15. An improved synthesis of the radiolabeled prostate-specific membrane antigen inhibitor, [18F]DCFPyL - PMC, accessed August 25, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC5516894/
16. Automated synthesis of [18F]DCFPyL via direct radiofluorination and validation in preclinical prostate cancer models, accessed August 25, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC4854855/
17. Silicon-[ 18 F]Fluorine Radiochemistry: Basics, Applications and Challenges - MDPI, accessed August 25, 2025, https://www.mdpi.com/2076-3417/2/2/277
18. Treatment Modification After Initiating Second-Line Medication for ..., accessed August 25, 2025, https://www.cancernetwork.com/view/navigating-the-landscape-of-psma-pet-imaging-agents-in-prostate-cancer
19. Study compares 18F-based PSMA radiotracers to [68Ga]Ga-PSMA-11 - Urology Times, accessed August 25, 2025, https://www.urologytimes.com/view/study-compares-18f-based-psma-radiotracers-to-68ga-ga-psma-11
20. 18F-PSMA-11 Versus 68Ga-PSMA-11 Positron Emission Tomography/Computed Tomography for Staging and Biochemical Recurrence of Prostate Cancer: A Prospective Double-blind Randomised Cross-over Trial - ResearchGate, accessed August 25, 2025, https://www.researchgate.net/publication/361182871_18F-PSMA-11_Versus_68Ga-PSMA-11_Positron_Emission_TomographyComputed_Tomography_for_Staging_and_Biochemical_Recurrence_of_Prostate_Cancer_A_Prospective_Double-blind_Randomised_Cross-over_Trial
21. PYLARIFY® (piflufolastat F 18) injection, for intravenous use - This label may not be the latest approved by FDA. For current labeling information, please visit https://www.fda.gov/drugsatfda, accessed August 25, 2025, https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214793s000lbl.pdf
22. Pylarify (piflufolastat F 18) dosing, indications, interactions, adverse effects, and more, accessed August 25, 2025, https://reference.medscape.com/drug/pylarify-piflufolastat-F-18-4000221
23. Piflufolastat F-18 ( 18 F-DCFPyL) for PSMA PET imaging in prostate cancer - ResearchGate, accessed August 25, 2025, https://www.researchgate.net/publication/360772612_Piflufolastat_F-18_18_F-DCFPyL_for_PSMA_PET_imaging_in_prostate_cancer
24. Pylclari, INN-piflufolastat (18F), accessed August 25, 2025, https://ec.europa.eu/health/documents/community-register/2023/20230724159723/anx_159723_en.pdf
25. Lantheus Receives U.S. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer, accessed August 25, 2025, https://investor.lantheus.com/news-releases/news-release-details/lantheus-receives-us-fda-approval-pylarifyr-piflufolastat-f-18
26. Pylarify (piflufolastat F 18) FDA Approval History - Drugs.com, accessed August 25, 2025, https://www.drugs.com/history/pylarify.html
27. Pylclari | European Medicines Agency (EMA), accessed August 25, 2025, https://www.ema.europa.eu/en/medicines/human/EPAR/pylclari
28. Prostate Cancer Diagnostic Imaging Agent | PYLARIFY®, accessed August 25, 2025, https://www.pylarify.com/
29. Detecting & Monitoring Prostate Cancer with PYLARIFY, accessed August 25, 2025, https://www.pylarify.com/patient/about
30. Curium Announces Pylclari® – an Innovative 18F-PSMA PET Tracer Indicated in Patients With Prostate Cancer – is now available in Spain, accessed August 25, 2025, https://www.curiumpharma.com/2024/09/10/pylclari-spain-available/
31. Lantheus Presents Data Reinforcing Real-World Clinical Utility of Piflufolastat F 18 PET Scanning in Men with Recurrent Prostate Cancer and Low PSA Levels, accessed August 25, 2025, https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-presents-data-reinforcing-real-world-clinical-utility
32. Lantheus Announces Presentations Featuring PYLARIFY® (Piflufolastat F18), PYLARIFY AI™ and NM-01 (PD-L1 Imaging) at the 2022 Society for Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting - Investor Relations | Lantheus Holdings, Inc., accessed August 25, 2025, https://lantheusholdings.gcs-web.com/news-releases/news-release-details/lantheus-announces-presentations-featuring-pylarifyr
33. Lantheus Receives U.S. FDA Approval of PYLARIFY® (piflufolastat F 18) Injection, the First and Only Commercially Available PSMA PET Imaging Agent for Prostate Cancer, accessed August 25, 2025, https://zerocancer.org/stay-informed/prostate-cancer-news/lantheus-receives-us-fda-approval-pylarifyr-piflufolastat-f-18
34. Curium Further Expands European Availability of PYLCLARI – an Innovative 18F-PSMA PET Radiopharmaceutical Indicated in Patients with Prostate Cancer - BioSpace, accessed August 25, 2025, https://www.biospace.com/press-releases/curium-further-expands-european-availability-of-pylclari-an-innovative-18f-psma-pet-radiopharmaceutical-indicated-in-patients-with-prostate-cancer
35. PYLCLARI® (piflufolastat (18F)) - BV Cyclotron VU, accessed August 25, 2025, https://www.cyclotron.nl/pylclari-piflufolastat-18f/
36. Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it, accessed August 25, 2025, https://www.canjurol.com/html/subscriber/Spdf/V30I01/CJU_V30_I1_10_DrRowe.pdf
37. A Phase 2/3 Prospective Multicenter Study of the Diagnostic ..., accessed August 25, 2025, https://www.auajournals.org/doi/10.1097/JU.0000000000001698
38. A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY) - PubMed, accessed August 25, 2025, https://pubmed.ncbi.nlm.nih.gov/33634707/
39. ASCO 2022: Piflufolastat F18-PET/CT in Patients With Prostate Cancer: An Analysis of OSPREY (Cohorts A and B) Standardized Uptake Value Results Stratified by PSA and Gleason Score - UroToday, accessed August 25, 2025, https://www.urotoday.com/conference-highlights/asco-2022/asco-2022-prostate-cancer/137687-asco-2022-abstract-5024-piflufolastat-f18-pet-ct-in-patients-with-prostate-cancer-an-analysis-of-osprey-cohorts-a-and-b-standardized-uptake-value-suv-results-stratified-by-psa-and-gleason-score.html
40. Piflufolastat F 18-PET/CT in patients with prostate cancer: An ..., accessed August 25, 2025, https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.5024
41. Real-world data show impact of piflufolastat F18 on prostate cancer ..., accessed August 25, 2025, https://www.urologytimes.com/view/real-world-data-show-impact-of-piflufolastat-f18-on-prostate-cancer-management
42. The Journal of Urology: OSPREY: A Phase 2/3 Study of the Diagnostic Accuracy of 18 F-DCFPyL-PET/CT in Prostate Cancer Patients - AUANews, accessed August 25, 2025, https://auanews.net/issues/articles/2021/july-2021/osprey-a-phase-2/3-study-of-the-diagnostic-accuracy-of-18-f-dcfpyl-pet/ct-in-prostate-cancer-patients
43. Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer - larvol clin, accessed August 25, 2025, https://clin.larvol.com/trial-detail/NCT03739684
44. SNMMI 2025: 18F-Piflufolastat PET/CT in Patients with ... - UroToday, accessed August 25, 2025, https://www.urotoday.com/conference-highlights/snmmi-2025/161473-snmmi-2025-18f-piflufolastat-pet-ct-in-patients-with-biochemically-recurrent-prostate-cancer-a-condor-sub-analysis-of-positive-predictive-value-in-the-prostate-prostatic-bed-stratified-by-psa.html
45. Piflufolastat f 18 (intravenous route) - Side effects & uses - Mayo Clinic, accessed August 25, 2025, https://www.mayoclinic.org/drugs-supplements/piflufolastat-f-18-intravenous-route/description/drg-20516701
46. Learn How to Use PYLARIFY® - Dosing & Administration, accessed August 25, 2025, https://www.pylarify.com/support/using-pylarify
47. Clinical Guidelines From NCCN, AUA, & SNMMI | PYLARIFY®, accessed August 25, 2025, https://www.pylarify.com/about-pylarify/clinical-guidelines
48. Explore PYLARIFY® Safety Data & Side Effects, accessed August 25, 2025, https://www.pylarify.com/efficacy-safety/safety
49. Find Resources for You and Your Patients | PYLARIFY®, accessed August 25, 2025, https://www.pylarify.com/support/practice-patient-resources
50. 18 F-DCFPyL detected additional PSMA-positive lesions 1 - PYLARIFY, accessed August 25, 2025, https://www.pylarify.com/diagnostic-performance/f-18-detection
51. Comparison of 18F-Based PSMA Radiotracers with [68Ga]Ga-PSMA-11 in PET/CT Imaging of Prostate Cancer-a Systematic Review and Meta-Analysis - Beyond the Abstract - UroToday, accessed August 25, 2025, https://www.urotoday.com/recent-abstracts/urologic-oncology/prostate-cancer/149002-comparison-of-18f-based-psma-radiotracers-with-68ga-ga-psma-11-in-pet-ct-imaging-of-prostate-cancer-a-systematic-review-and-meta-analysis-beyond-the-abstract.html
52. Comparison of 18F-DCFPyL and 68Ga-PSMA-11 for 177Lu-PSMA-617 therapy patient selection - PMC, accessed August 25, 2025, https://pmc.ncbi.nlm.nih.gov/articles/PMC11238039/
53. 18F-DCFPyL PET/CT for Initially Diagnosed and Biochemically Recurrent Prostate Cancer: Prospective Trial with Pathologic Confirmation | Radiology - RSNA Journals, accessed August 25, 2025, https://pubs.rsna.org/doi/abs/10.1148/radiol.220218
54. Comparison of 68 Ga-PSMA-11 and 18 F-Fluciclovine PET/CT in a Case Series of 10 Patients with Prostate Cancer Recurrence - Journal of Nuclear Medicine, accessed August 25, 2025, https://jnm.snmjournals.org/content/59/5/789
55. Comparison of 18F-based PSMA radiotracers with [68Ga]Ga-PSMA-11 in PET/CT imaging of prostate cancer-a systematic review and meta-analysis - PubMed, accessed August 25, 2025, https://pubmed.ncbi.nlm.nih.gov/38017295/
56. Piflufolastat F 18 Recruiting Phase 0 Trials for Prostate Cancer Treatment | DrugBank Online, accessed August 25, 2025, https://go.drugbank.com/drugs/DB14805/clinical_trials?conditions=DBCOND0062462&phase=0&purpose=treatment&status=recruiting
57. Piflufolastat F 18 Recruiting Phase 4 Trials for Metastatic Castration-Resistant Prostate Cancer (mCRPC) Diagnostic - DrugBank, accessed August 25, 2025, https://go.drugbank.com/drugs/DB14805/clinical_trials?conditions=DBCOND0069854&phase=4&purpose=diagnostic&status=recruiting
58. Piflufolastat F 18 Recruiting Phase 1 Trials for Radical Prostatectomy Treatment - DrugBank, accessed August 25, 2025, https://go.drugbank.com/drugs/DB14805/clinical_trials?conditions=DBCOND0044221&phase=1&purpose=treatment&status=recruiting