PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
Status:
Recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
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.