PSMA PET with PYLARIFY® significantly improved specificity over standard imaging while maintaining comparable sensitivity and delivering high PPV and NPV2


PSMA PET IMAGING CAN CHANGE HOW YOU INTEND TO TREAT YOUR PATIENTS WITH PROSTATE CANCER3

Michael Lutz, MD, explains the benefits of PSMA PET imaging for prostate cancer diagnosis and initial staging.

In a post-hoc analysis, PYLARIFY® achieved the success criteria for sensitivity and specificity across lymph nodes >5 mm2

Chart showing PYLARIFY® achieved high specificity, PPV, and NPV
  • In the pre-specified analysis, the specificity co-primary endpoint with PYLARIFY® (piflufolastat F 18) injection PET/CT was met (the lower limits of the 95% CIs for all readers were >80%), but the sensitivity co-primary endpoint was not met, in part due to limitations in PET/CT image resolution for tumors smaller than 5 mm2,4,5
  • PYLARIFY® PET/CT achieved high PPV (range: 72%-81%) and NPV (81%-84%), reducing the risk of undertreatment3
In the CONDOR trial, 78.6% of changes to patients' treatment plans were based on positive PYLARIFY® PET/CT findings

Informed Decision-making

Following PYLARIFY® PET/CT imaging, 27% of patients for whom standard imaging showed only localized disease were revealed to have N1 or M1 disease after PSMA PET with PYLARIFY®.* This upstaging of disease may have a substantial impact on treatment management decisions.6*

*Change in treatment plan was not an endpoint in OSPREY. Future studies will be necessary to demonstrate whether PYLARIFY® PET/CT-directed changes in management lead to improved outcomes.2

INFORMED DECISION-MAKING WITH PSMA PET3

Michael David Lutz, MD, highlights the importance of PSMA PET imaging for treatment management.

PYLARIFY® achieved high PPV, specificity, and NPV compared to standard imaging while maintaining comparable sensitivity2

  • PYLARIFY® PET/CT specificity was significantly higher than with standard imaging (97.9% vs 65.1%)
  • PYLARIFY® PET/CT nearly tripled the PPV compared to standard imaging (86.7% vs 28.3%)
  • PYLARIFY® PET/CT achieved similar sensitivity to standard imaging
Review the OSPREY clinical trial design (OSPREY Cohort A)2

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)

OSPREY assessed the sensitivity, specificity, PPV, and NPV in pelvic lymph nodes for PYLARIFY® PET/CT

Clinical trial design for the Osprey trial

In Cohort A, OSPREY included patients across a broad range of PSA levels, disease stages, age ranges, and Gleason scores

Clinical trial design for the Osprey trial Clinical trial design for the Osprey trial
Clinical trial design for the Osprey trial Clinical trial design for the Osprey trial

n=268; except for Distant Metastases (n=266) and Median PSA (n=267).
Stage at time of study entry or most recent prior to entry.

PYLARIFY® PET/CT's HIGH PPV AND NPV RATES INDICATE THAT A

POSITIVE OR NEGATIVE RESULT FOR NODAL DISEASE IS MORE INFORMATIVE THAN STANDARD IMAGING,

allowing physicians to treat with more confidence2

REVIEW CASE STUDIES FROM PYLARIFY® CLINICAL TRIALS

CI=confidence interval; PLND=pelvic lymph node dissection; CT=computed tomography; NPV=negative predictive value; 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.

References

  1. FDA clearance letter for aPROMISE X. Food and Drug Administration. April 29, 2022.
  2. 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
  3. PYLARIFY® [package insert]. North Billerica, MA: Progenics Pharmaceuticals, Inc., a Lantheus company.
  4. Crippa F, Leutner M, Belli F, et al. Which kinds of lymph node metastases can FDG PET detect? A clinical study in melanoma. J Nucl Med. 2000;41(9):1491-1494.
  5. Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1-14. doi:10.1177/1758835919876828
  6. Carroll PR, Probst S, Rowe SP, et al. Changes to initial risk assessment and intended patient management in high-risk prostate cancer: an exploratory analysis of cohort A from the OSPREY trial. J Urol. 2021;206(suppl 3):e181-e182.