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NCT06074510 · ClinicalTrials.gov registry record · Phase 4
PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer
A Phase 4 study of Prostate Cancer, sponsored by Lantheus Medical Imaging.
- Active
- Registry status
- Phase 4
- Development phase
- 274
- Enrollment target
- 14
- Study locations
NCT06074510: Active Phase 4 study of Prostate Cancer, sponsored by Lantheus Medical Imaging.
NCT06074510 is a Phase 4 study of Prostate Cancer that is active but no longer recruiting, run by Lantheus Medical Imaging. The registered enrollment target is 274 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% lower). The trial reports 14 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06074510, a Phase 4 study of Prostate Cancer, is active but no longer recruiting, sponsored by Lantheus Medical Imaging.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 274 participants
- Enrollment target
- 14
- Study locations
Study 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.
Primary Outcome
The proportion of participants with prostate cancer in whom PYLARIFY PET detected previously occult intraprostatic ISUP grade ≥3 lesions as assessed by pathology, or in whom PYLARIFY PET detected the presence of either/or extraprostatic extension, seminal vesicle invasion, regional lymph node involvement, distant metastases, divided by the number of subjects who undergo a PYLARIFY PET scan
Conditions Studied
Interventions
- DRUG Piflufolastat F 18 Intravenous Solution [PYLARIFY]
Study Locations (14)
California
- Hoag Cancer Center - Irvine
- Tower Urology - Los Angeles
- University of California San Francisco - San Francisco
Michigan
- Karmanos Cancer Institute Wayne State University - Detroit
- BAMF Health - Grand Rapids
Alabama
- University of Alabama at Birmingham - Birmingham
Georgia
- Emory University - Atlanta
Iowa
- University of Iowa Health Care - Iowa City
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Massachusetts General Hospital - Boston
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2026-09 |
| Phase | Phase 4 |
What the registry record for NCT06074510 still lists
NCT06074510 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 1 intervention - of which Piflufolastat F 18 Intravenous Solution [PYLARIFY] is the first listed.
NCT06074510 lists 14 locations in 11 states (California, Michigan, Alabama).
Frequently Asked Questions
What is clinical trial NCT06074510 about?
NCT06074510 is a clinical study titled "PYLARIFY® PET/CT or PET/MRI in Men With Favorable Intermediate Risk (FIR) Prostate Cancer". 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 ...
What is the current status of trial NCT06074510?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 274 participants. The study started on 2024-02-08. Estimated completion is 2026-09.
What conditions does trial NCT06074510 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT06074510?
The interventions under investigation include: Piflufolastat F 18 Intravenous Solution [PYLARIFY] (DRUG).
Who is sponsoring clinical trial NCT06074510?
This trial is sponsored by Lantheus Medical Imaging, which has 22 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06074510 being conducted?
This trial has 14 study locations across Alabama, California, Georgia, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06074510's enrollment target sits among peer trials
274 177th of 735 higher than 558 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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