NCT06074510Active, not recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 274 (estimated)
- First submitted
- 3 Oct 2023
- Start date
- 8 Feb 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Lantheus Medical Imaging
- Diseases
- Prostate cancer
- NCT number
- NCT06074510
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 274
- From 8 Feb 2024 to the primary completion date, Sept 2026
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emory University Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Karmanos Cancer Institute - Wayne State University Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| BAMF Health Coordinator of this site? Confirm its status | Grand Rapids | United States | Unknown status |
| University of Iowa Health Care Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Hoag Cancer Center Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Tower Urology Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Oregon Health Science University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.