PSMA PET clinical guidelines

Supported in major clinical guidelines

The appropriate use of PSMA PET imaging for evaluating prostate cancer is supported by recommendations in national clinical practice guidelines (NCCN) and professional society guidance (SNMMI, AUA).1-3

The NCCN Guidelines® state that because of the increased sensitivity and specificity of PSMA-PET tracers for detecting micrometastatic disease compared to CT, MRI, and bone scan at both initial staging and BCR [biochemical recurrence], PSMA-PET/CT or PSMA-PET/MRI may serve as a more effective frontline imaging tool for these patients.1

  • Initial staging
  • Detection of biochemically recurrent disease
  • Workup for progression of disease in bone and soft tissues

The SNMMI Appropriate Use Criteria are generally consistent with the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).

According to Society of Nuclear Medicine and Molecular Imaging (SNMMI) Appropriate Use Criteria, PSMA PET is appropriate for:

  • Men with newly diagnosed unfavorable intermediate-, high-, or very-high-risk PCa
  • Men with BCR after radical prostatectomy or radiation therapy

According to the AUA and Society of Urologic Oncology (SUO):

For BCR without metastatic disease after exhaustion of local treatment options:

  • In patients with PSA recurrence after failure of local therapy who are at higher risk for the development of metastases (eg, PSADT <12 months), clinicians should perform periodic staging evaluations consisting of cross-sectional imaging (CT, MRI) and technetium bone scan and/or preferably PSMA PET imaging
  • Clinicians should utilize PSMA PET imaging preferentially, where available, in patients with PSA recurrence after failure of local therapy as an alternative to conventional imaging due to its greater sensitivity or in the setting of negative conventional imaging

BCR=biochemical recurrence; CT=computed tomography; MRI=magnetic resonance imaging; PCa=prostate cancer; PET=positron emission tomography; PSA=prostate-specific antigen; PSADT=PSA doubling time; PSMA=prostate-specific membrane antigen.

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

INDICATION

PYLARIFY TRUVU (piflufolastat F 18) Injection is 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.
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Risk of Image Misinterpretation

Imaging interpretation errors can occur with PYLARIFY TRUVU imaging. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of PYLARIFY TRUVU for imaging biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. The performance of PYLARIFY TRUVU for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by risk factors such as Gleason score and tumor stage. PYLARIFY TRUVU uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.

Hypersensitivity Reactions

Monitor patients for hypersensitivity reactions, particularly those with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

Radiation Risks

PYLARIFY TRUVU exposes patients to radiation. Radiation exposure is associated with a dose-dependent increased risk of cancer. Ensure safe handling and preparation procedures to protect patients and health care workers from unintentional radiation exposure. Advise patients to hydrate before and after administration and to void frequently after administration.

Adverse Reactions

The most frequently reported adverse reactions were headaches, dysgeusia and fatigue, occurring at rate of ≤2% during clinical studies. In addition, a delayed hypersensitivity reaction was reported in one patient (0.2%) with a history of allergic reactions.

Drug Interactions

Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of PYLARIFY TRUVU in prostate cancer. The effect of these therapies on performance of PYLARIFY TRUVU PET has not been established.

To report suspected adverse reactions for PYLARIFY TRUVU, call 1-800-362-2668 or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for PYLARIFY TRUVU.

REFERENCES

1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.5.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed March 26, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Appropriate use criteria for prostate-specific membrane antigen (PSMA) PET imaging. Society of Nuclear Medicine & Molecular Imaging. Updated March 2022. Accessed April 21, 2026. https://snmmi.org/Web/Clinical-Practice/Appropriate-Use-Criteria/Articles/Appropriate-Use-Criteria-for-Prostate-Specific-Membrane-Antigen--PSMA--PET-Imaging.aspx  3. Lowrance W, Dreicer R, Jarrard DF, et al. Updates to advanced prostate cancer: AUA/SUO guideline (2023). J Urol. 2023;209(6):1082-1090.