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.