Using PET scans to find prostate cancer after surgery in patients with rising PSA levels
Official title: RhPSMA-7.3(18F)-PET Scan to Detect Prostate Cancer in Patients with Early PSA Recurrence
Run by AdventHealth · NCT06617481 · Data updated 2026-11-12
This study is testing if a special PET scan can help find prostate cancer in men who have had surgery and have rising PSA levels, to see if it works better than the current methods.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 30 (estimated) |
| Sponsor | AdventHealth Academic / other |
| Locations | 1 site (Orlando, Florida) |
| Status | Recruiting |
| Started | September 20, 2024 |
| Main results expected | September 5, 2027 |
| Study ends | October 10, 2027 |
| Registry record updated | October 24, 2024 |
| Trial ID | NCT06617481 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men with a history of localized prostate cancer who have undergone radical prostatectomy and have a PSA level between 0.1 and 0.5 ng/ml.
✕Probably not a fit
Patients currently receiving androgen deprivation therapy or those scheduled for other imaging procedures within 24 hours will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effectiveness of the flotufolastat F-18 PET scan in detecting prostate cancer in patients who have undergone radical prostatectomy and are experiencing low levels of rising PSA. The PET scan is FDA approved for identifying prostate-specific membrane antigen (PSMA) positive lesions in men with suspected cancer recurrence. If the initial scan does not reveal cancer and PSA levels continue to rise, a follow-up PET scan will be conducted. This approach aims to improve detection rates compared to current imaging methods.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of prostate cancer in patients with low PSA levels, allowing for timely and appropriate treatment.
How similar studies have gone: Other studies have shown promising results with similar PET imaging approaches for detecting prostate cancer, indicating potential for success in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy. * An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5 Exclusion Criteria: * Patients who are planned to have an x-ray contrast agent or other PET radiotracer \& less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan. * Patients currently receiving Androgen Deprivation Therapy (ADT).
Where it's running
-
AdventHealth
Orlando, Florida, United States Recruiting
Study contacts
- Study coordinator: AdventHealth AdventHealth Oncology Research
- Email: CFD.ResearchOncology@AdventHealth.com
- Phone: 407-303-2090
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.