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

Eligibility Criteria

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 judged by the investigator.
* Patients who have already received salvage therapy.