PYLARIFY® PET/CT Case Studies
In patients with high-risk PCa who were candidates for initial definitive therapy, PYLARIFY® PET/CT identified extra-pelvic lesions in 12.3% of patients, which were not detected with standard imaging2
PET Image with PYLARIFY®
A patient in OSPREY with baseline staging T1c N0 M0, PSA 13.68 ng/mL, and Gleason score 4+5. CT imaging (not shown) showed no evidence of metastatic disease, and bone scintigraphy showed changes of left hip arthroplasty and increased tracer uptake in the anterior superior iliac spine (shown with arrow), but otherwise normal. PYLARIFY® (piflufolastat F 18) injection showed multifocal osseous lesions on the spine, ribs, pelvis, and right clavicle. Biopsy of left transverse process of L3 confirmed osseous metastatic disease (M1b).2
In CONDOR, across the 3 readers, PYLARIFY® detected at least 1 previously occult lesion in 59.6%-65.9% of patients3,4
- 71-year-old patient had a Gleason score of 4+3, history of radical prostatectomy, EBRT with PSA 1.92 ng/mL, and equivocal results on 18F fluciclovine PET/CT scan
- PYLARIFY® showed left common iliac lesions and multiple retroperitoneal para/peri aortic lymph node lesions
- Biopsy of retroperitoneal lymph node confirmed prostate cancer
CT=computed tomography; EBRT=external beam radiation therapy; GnRH=gonadotropin-releasing hormone; MRI=magnetic resonance imaging; PCa=prostate cancer; PET=positron emission tomography; PSA=prostate-specific antigen.
INDICATION & IMPORTANT
PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent 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.
- FDA clearance letter for aPROMISE X. Food and Drug Administration. April 29, 2022.
- Pienta KJ, Gorin MA, Rowe SP, et al. 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). J Urol. 2021;206(1):52-61. doi:10.1097/JU.0000000000001698
- 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. doi:10.1158/1078-0432.CCR-20-4573
- Data on file. New York, NY: Progenics Pharmaceuticals, Inc.; 2021.