- Efficacy: High-risk PCa: OSPREY COHORT A
- Efficacy: Biochemically recurrent PCa: CONDOR
- Locally Recurrent or New/Progressive PCa: OSPREY COHORT B
PATIENTS WITH LOCALLY RECURRENT OR NEW/PROGRESSIVE METASTATIC PCa WITH PERSISTENT ELEVATED PSA LEVEL
PYLARIFY® PET/CT detected PSMA-positive lesions in 57.6% (19/33) of patients with recurrent prostate cancer and no evidence of distant metastases on conventional imaging2
- 11 of 19 patients underwent targeted biopsy and 10/11 (91%) were confirmed to have prostate cancer on pathology3
- 8 of 19 patients (42%) were not able to be biopsied3
In men post therapy with suspected recurrent or metastatic disease, PYLARIFY® PET/CT demonstrated high sensitivity and PPV in all sites of disease2
- 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%), respectively2
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 (Cohort B; n=117)
In Cohort B, OSPREY assessed sensitivity and PPV in men with radiologic evidence of recurrence
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
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
- Data on file. North Billerica, MA: Progenics Pharmaceuticals, Inc.; 2021.