Recurrent Prostate Cancer and Low PSA Levels: Can an Emerging PSMA PET Agent Have an Impact?

In a secondary analysis from the phase 3 CONDOR trial of men with biochemically recurrent prostate cancer, researchers found that utilizing piflufolastat F 18, a prostate-specific membrane antigen (PSMA)-targeted radiopharmaceutical, prior to positron emission tomography (PET) scanning led to changes in intended management in 39.1 percent of patients with a prostate-specific antigen (PSA) level below 0.5 ng/mL.^1,2

For the study, presented recently at 2023 American Society of Clinical Oncology (ASCO) Genitourinary Cancers (GU) Symposium in San Francisco, researchers reviewed data from a subset of 69 patients from the CONDOR trial who had a PSA level below 0.5 ng/mL.¹ Prior to PET imaging, the patients received a single dose injection of piflufolastat F 18 (PYLARIFY, Lantheus Holdings). Patients also completed pre- and post-imaging questionnaires about the intended management of their prostate cancer, according to the study.

The researchers noted that piflufolastat F 18 led to changes in intended treatment for 27 patients (39.1 percent). For 20 of the 27 patients (74.1 percent), the changes resulted in an escalation of treatment from either local salvage therapy to systemic therapy, or a shift from observation to initiating treatment. The study authors noted that piflufolastat F 18 identified lesions in 18 of the 20 patients who had an intensification of treatment.¹

“PYLARIFY has the potential to contribute meaningful and actionable information that can be used to personalize treatment plans in men with low PSA levels,” noted lead study author Frederic Pouliot, M.D., Ph.D., F.R.C.S.C, an associate professor in the Department of Surgery at Laval University in Quebec City, Quebec, Canada. “The data we presented at ASCO GU emphasize the clinical utility of piflufolastat F 18 to assess the relevance and applicability of intended treatment management plans.”

In the previous CONDOR trial involving 205 men with recurrent prostate cancer, 131 patients (63.9 percent) had changes in disease management resulting from administration of piflufolastat F 18 prior to PET imaging, according to the study.²

(Editor’s note: For related content, see “Is PSMA PET/CT More Beneficial than Bone Scintigraphy in Detecting Bone Lesions in Cases of High-Risk Prostate Cancer?” and “Meta-Analysis Assesses Impact of PSMA PET Imaging on Treatment Outcomes for Prostate Cancer Recurrence.”)

References

1. Lantheus Holdings. Lantheus presents data reinforcing real-world clinical utility of piflufolastat F 18 PET scanning in men with recurrent prostate cancer and low PSA levels. GlobeNewsWire. Available at: https://www.globenewswire.com/news-release/2023/02/16/2609747/0/en/Lantheus-Presents-Data-Reinforcing-Real-World-Clinical-Utility-of-Piflufolastat-F-18-PET-Scanning-in-Men-with-Recurrent-Prostate-Cancer-and-Low-PSA-Levels.html . Published February 16, 2023. Accessed February 16, 2023.

2. Morris MJ, Rowe SP, Gorin MA, et al. Diagnostic performance of 18F-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.