Intrapatient Comparison of Urinary Radioactivity Following Piflufolastat (18F) and Flotufolastat (18F) PET in Men With Low PSA Biochemical Recurrence of Prostate Cancer Following Radical Prostatectomy
NCT ID: NCT06604442
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
55 participants
INTERVENTIONAL
2024-12-04
2025-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)
Each patient will be administered a single dose of piflufolastat (18F) on Day 1, followed by a PET scan. At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days, all patients will be administered a single dose of flotufolastat (18F) followed by a PET scan.
Flotufolastat (18F)
Positron emission tomography (PET)
piflufolastat (18F)
Positron emission tomography (PET)
Interventions
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Flotufolastat (18F)
Positron emission tomography (PET)
piflufolastat (18F)
Positron emission tomography (PET)
Eligibility Criteria
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Inclusion Criteria
* Documented history of localized adenocarcinoma of the prostate with prior curative intent treatment with RP and undetectable PSA post-surgery, experiencing BCR of prostate cancer.
* At least 6 months must have elapsed after RP.
* Low PSA BCR defined as PSA ≤0.5 ng/mL.
* Scheduled by their treating physician to receive a PSMA (18F) PET scan.
* Written informed consent obtained from the patient and ability for the patient to comply with the requirements of the study.
Exclusion Criteria
* Patients who are planned to have an x-ray contrast agent or any other PET radiotracer within 24 hours prior to either PSMA PET scan.
* Patients who have already received a piflufolastat (18F) PET scan prior to providing informed consent for this study.
* Patients participating in an interventional clinical trial within 30 days and having received an IP within five biological half-lives prior to either of the PSMA PET scans in this study.
* Patients with known hypersensitivity to the active substance or to any of the excipients of piflufolastat (18F) or flotufolastat (18F).
* Patients who have previously undergone a cystectomy or have renal failure, or have other conditions that may significantly affect urinary output, as judged by the investigator.
* Patients who have already received salvage therapy.
18 Years
MALE
No
Sponsors
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Aixial Group
INDUSTRY
Blue Earth Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Brian Helfand, M.D.
Role: PRINCIPAL_INVESTIGATOR
Endeavor Health NorthShore Hospital
Locations
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Mayo Clinic
Phoenix, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Tower Urology
Los Angeles, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Endeavor Health- Glenbrook Hospital
Glenview, Illinois, United States
XCancer Omaha/Urology Cancer Center
Omaha, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Urology San Antonio
San Antonio, Texas, United States
Countries
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Other Identifiers
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BED-PSMA-411
Identifier Type: -
Identifier Source: org_study_id
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