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PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Phase IV
Eligibility
18 Years and older, Male
Study Type
Diagnostic
NCT ID
NCT06074510
Protocol IDs
PYL4301 (primary)
NCI-2024-00237
Study Sponsor
Lantheus Medical Imaging

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.

Eligibility

  1. Patients must have the ability to understand and sign an approved informed consent form (ICF)
  2. Patients must have the ability to understand and comply with all protocol requirements
  3. Patients must be = 18 years of age
  4. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  5. Patients with life expectancy of at least 13 months as determined by the investigator
  6. Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:
  7. 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
  8. ISUP Grade Group 1 or 2
  9. <50% biopsy cores positive (e.g., <6 of 12 cores) Note: Date of the prostate biopsy should be no sooner that 2 weeks and no later than 3 months prior to PYLARIFY PET imaging

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.