NCT06074510

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

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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Piflufolastat F 18 Intravenous Solution [PYLARIFY]	Participants will receive a single dose of 333 MBq (9 mCi) \[296 MBq-370 MBq (8 mCi - 10 mCi)\] PYLARIFY injection followed by a single whole-body PET/CT or PET/MRI scan acquired at 1 to 2 hours post-dosing

Timeline

• Start date: 2024-02-08
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-10-10
• Last updated: 2025-09-11

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study