CompletedPhase 4

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

United States62 participantsStarted 2024-12-04

Plain-language 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

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 j…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET.

Timeframe: piflufolastat (18F) administration and PET on Day 1; and flotufolastat (18F) administration and PET at least 24 hours after the piflufolastat (18F) scan but within 10 calendar days

Trial details

NCT IDNCT06604442

SponsorBlue Earth Diagnostics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-29

Results submitted2026-03-04

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