Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Peter Carroll
Headshot of Peter Carroll
Peter Carroll

Description

Summary

The purpose of this study is to learn whether PYLARIFY PET imaging (study scan) can safely and accurately detect the presence or absence of prostate cancer growing beyond the prostate gland in men with favorable intermediate risk prostate cancer.

Participants will receive a single dose of PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours after PYLARIFY injection. Participants with positive study scan results that are suspicious for prostate cancer outside of the prostate gland may be asked to undergo additional diagnostic test(s) and/or recommend certain treatment(s) for prostate cancer within 2 to 90 days after the study scan. Participants will be monitored for up to 12 months to collecting information about treatment they receive for prostate cancer and results of regular PSA blood draws if ordered by doctors for up to 12 months after the study scan.

Official Title

A Phase 4 Open-Label Multicenter Study of PYLARIFY® PET/CT or PET/MRI in Men With Newly Diagnosed Favorable Intermediate Risk (FIR) Prostate Cancer

Keywords

Prostate Cancer, Favorable Intermediate Risk, PYLARIFY, PET, Prostatic Neoplasms, Piflufolastat F 18 Intravenous Solution [PYLARIFY], PYLARIFY PET

Eligibility

Locations

  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Tower Urology accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at UCSF

  • Peter Carroll
    My research interests include identifying clinical and pathologic determinants of prostate cancer detection, recurrence, progression, and mortality; discovering novel biomarkers for prostate cancer diagnostics and prognostics, developing evidence-based guidelines for improved management of prostate cancer including surveillance alone, refining the use and outcomes of robotic s…

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lantheus Medical Imaging
ID
NCT06074510
Phase
Phase 4 Prostate Cancer Research Study
Study Type
Interventional
Participants
Expecting 274 study participants
Last Updated