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

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

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

This is a multi-center, prospective intra-patient comparator study of urinary radioactivity (standardized uptake values [SUV]) following both piflufolastat (18F) and flotufolastat (18F) positron emission tomography (PET) in patients with low prostate-specific antigen (PSA; ≤0.5 ng/mL) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy (RP).

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.