Phase 4
Completed N=62
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
Source: ClinicalTrials.gov NCT06604442 ↗Enrolled (actual)
62
Serious AEs
0.8%
Results posted
May 2026
Primary outcomePrimary: To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET. — 29.0; 10.9 ratio — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Compare Urinary Bladder Radioactivity Observed on Piflufolastat (18F) PET and Flotufolastat (18F) PET. |
29.0; 10.9 | <0.001 sig |
| SECONDARY Patient Level Detection Rates Following Piflufolastat (18F) PET and Flotufolastat (18F) PET |
27.3; 45.5 | — |
| SECONDARY Patient Level Detection Rates Stratified by PSA Level Following Piflufolastat (18F) PET and Flotufolastat (18F) PET |
52.4; 38.1; 41.2; 20.6 | — |
| SECONDARY Detection Rate for Prostate Bed and Local Recurrences by Subregion Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET |
18.2; 10.9; 7.3; 3.6; 3.6; 3.6 | — |
| SECONDARY Detection Rate for Pelvic Lymph Node (PLN) Following for Piflufolastat (18F) PET and Flotufolastat (18F) PET |
16.4; 14.5 | — |
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.
Data sourced from ClinicalTrials.gov (NCT06604442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.