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
1 other identifier
interventional
55
1 country
9
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 prostate-cancer
Started Dec 2024
Shorter than P25 for phase_4 prostate-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
December 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2025
CompletedSeptember 11, 2025
September 1, 2025
9 months
September 17, 2024
September 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
To compare urinary bladder radioactivity observed on piflufolastat (18F) PET and flotufolastat (18F) PET.
Difference in urinary bladder mean SUV (SUVmean) between piflufolastat (18F) and flotufolastat (18F).
Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days
Secondary Outcomes (1)
To assess the following for piflufolastat (18F) PET and flotufolastat (18F) PET: Detection rates; Detection rates stratified by PSA level; Prostate bed detection rates: local recurrences by subregion; Pelvic lymph node (PLN) detection rates
Screening, piflufolastat (18F) on Day 1, At least 24 hours after the piflufolastat (18F) scan, but within 10 calendar days
Study Arms (1)
piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET)
EXPERIMENTALEach 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.
Interventions
Positron emission tomography (PET)
Positron emission tomography (PET)
Eligibility Criteria
You may qualify if:
- Male ≥18 years of age at Visit 1 (Screening).
- 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.
You may not qualify if:
- Patients with any medical condition or circumstance (including receiving an IP) that the investigator believes may compromise the data collected or lead to a failure to fulfill the study requirements.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Blue Earth Diagnosticslead
- Aixial Groupcollaborator
Study Sites (9)
Mayo Clinic
Phoenix, Arizona, 85054, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Tower Urology
Los Angeles, California, 90048, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Endeavor Health- Glenbrook Hospital
Glenview, Illinois, 60026, United States
XCancer Omaha/Urology Cancer Center
Omaha, Nebraska, 68130, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Helfand, M.D.
Endeavor Health NorthShore Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2024
First Posted
September 19, 2024
Study Start
December 4, 2024
Primary Completion
August 29, 2025
Study Completion
August 29, 2025
Last Updated
September 11, 2025
Record last verified: 2025-09