Comparing two PET scans for prostate cancer recurrence
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 study is testing which of two different PET scans is better at finding signs of prostate cancer returning in men who have low PSA levels after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Blue Earth Diagnostics Industry-sponsored |
| Locations | 9 sites (Phoenix, Arizona and 8 other locations) |
| Trial ID | NCT06604442 on ClinicalTrials.gov |
What this trial studies
This study compares the urinary radioactivity of two different PET scans, piflufolastat (18F) and flotufolastat (18F), in men who have low levels of prostate-specific antigen (PSA) after undergoing radical prostatectomy for prostate cancer. It is a multi-center, prospective intra-patient comparator study, meaning that each participant will serve as their own control by undergoing both types of scans. The goal is to assess the standardized uptake values (SUV) of these scans to determine which is more effective in detecting biochemical recurrence of prostate cancer.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have a documented history of localized prostate cancer and are experiencing biochemical recurrence with low PSA levels.
Not a fit: Patients who have received a piflufolastat (18F) PET scan prior to the study or those with certain medical conditions that may affect data collection will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of PET scans in detecting prostate cancer recurrence, leading to better patient management.
How similar studies have performed: Other studies have shown promise in using PET scans for prostate cancer detection, but this specific comparison of piflufolastat and flotufolastat is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Phoenix, Arizona and 8 other locations
- Mayo Clinic — Phoenix, Arizona, United States (Recruiting)
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
- Tower Urology — Los Angeles, California, United States (Recruiting)
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Endeavor Health- Glenbrook Hospital — Glenview, Illinois, United States (Recruiting)
- XCancer Omaha/Urology Cancer Center — Omaha, Nebraska, United States (Recruiting)
- Montefiore Medical Center — Bronx, New York, United States (Recruiting)
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
- Urology San Antonio — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Brian Helfand, M.D. — Endeavor Health NorthShore Hospital
- Study coordinator: Phillip Davis, MD
- Email: phillip.davis@blueearthdx.com
- Phone: +1 843 367 4652
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.