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

Completed · Phase 4

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID: NCT06604442
Run by: Blue Earth Diagnostics
People needed: 62
Starts: 2024-12-04
Expected to finish: 2025-08-29
Last updated by the study team: 2026-07-13

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.