Status:
ACTIVE_NOT_RECRUITING
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE4
Brief 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 wit...
Eligibility Criteria
Inclusion
- Patients must have the ability to understand and sign an approved informed consent form (ICF)
- Patients must have the ability to understand and comply with all protocol requirements
- Patients must be ≥ 18 years of age
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Patients with life expectancy of at least 13 months as determined by the investigator
- Patients must have confirmed favorable intermediate risk (FIR) adenocarcinoma of the prostate per 2023 NCCN guidelines. FIR risk group confirmation includes all the following:
- 1 intermediate risk factor (cT2b-cT2c or ISUP Grade Group 2 or PSA 10-20 ng/mL)
- ISUP Grade Group 1 or 2
- \<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
Exclusion
- Patients administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1 (PYLARIFY imaging)
- Previous Prostate cancer treatment including radiation, androgen deprivation therapy, brachytherapy, surgery, prostate ablation, hormonal therapies or investigational therapy
- Known hypersensitivity to the components of PYLARIFY or its analogs
- Patients with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or complete the study
- Patients who have any radiographic evidence of T3, N1 or M1 disease on SOC imaging (if performed)
Key Trial Info
Start Date :
February 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT06074510
Start Date
February 8 2024
End Date
September 1 2026
Last Update
September 11 2025
Active Locations (14)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
Hoag Cancer Center
Irvine, California, United States, 92618
3
Tower Urology
Los Angeles, California, United States, 90048
4
University of California San Francisco
San Francisco, California, United States, 94158