- Efficacy: High-risk PCa: OSPREY COHORT A
- Efficacy: Biochemically recurrent PCa: CONDOR
- Locally Recurrent or New/Progressive PCa: OSPREY COHORT B
- Safety
In patients with locally recurrent or new/progressive metastatic PCa with persistent elevated PSA level,
PSMA PET with PYLARIFY detected PSMA-positive lesions in 57.6% (19/33) of patients with no evidence of distant metastases on standard imaging, upstaging their disease and informing their treatment plan1
- 11 of 19 patients underwent targeted biopsy and 10/11 (91%) were confirmed to have prostate cancer on pathology2
- 8 of 19 patients (42%) were not able to be biopsied2
In men post therapy with suspected recurrent or metastatic disease, PYLARIFY PET/CT demonstrated high sensitivity and PPV in all sites of disease1
- In cohort B (93 evaluable patients, median prostate specific antigen 11.3 ng/ml), median sensitivity and positive predictive value for extraprostatic lesions were 95.8% (87.8%-99.0%) and 81.9% (73.7%-90.2%), respectively1
OSPREY was a robust, prospective, multicenter, phase 2/3 clinical trial of 385 men with either high-risk prostate cancer (Cohort A; n=268) or radiologic evidence of recurrence or metastatic disease (Cohort B; n=117)
In Cohort B, OSPREY assessed sensitivity and PPV in men with radiologic evidence of recurrence
*With subanalyses by region and PSA level.
See efficacy data
in patients with biochemically
recurrent PCa
Actor portrayal
CT=computed tomography; MRI=magnetic resonance imaging; PCa=prostate cancer; PET=positron emission tomography; PPV=positive predictive value; PSA=prostate-specific antigen; PSMA=prostate-specific membrane antigen.
INDICATION & IMPORTANT
SAFETY INFORMATION
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.
Radiation Risks
Diagnostic radiopharmaceuticals, including PYLARIFY, expose 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.
INDICATION
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.
References
- 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
- Data on file. Bedford, MA: Progenics Pharmaceuticals, Inc.; 2024.