Study on the Impact of Fluciclovine (18F) PET Scans for Prostate Cancer Management After Inconclusive PSMA PET Imaging
Sponsor: Blue Earth Diagnostics
ClinicalTrials ID:NCT07569926
This clinical trial is exploring how fluciclovine (18F) PET scans can help manage prostate cancer in patients who have had unclear results from a PSMA PET scan during a recurrence of the disease.
Patient Parameters
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Program Overview
The study aims to see if using fluciclovine (18F) PET scans can change the management of prostate cancer in patients who have had a negative or unclear PSMA PET scan when their cancer has returned after treatment.
Description
This is a Phase 4 study involving multiple medical centers. It is designed to see if fluciclovine (18F) PET scans can help doctors make better decisions about treating prostate cancer in patients whose PSMA PET scans did not provide clear results during a recurrence of the disease. The study will look at how these scans might change the way doctors manage the cancer.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 or older.
- Suspected return of prostate cancer after previous treatment, with a negative or unclear PSMA PET scan within 45 days before the fluciclovine (18F) PET/CT scan.
- Rising PSA levels after prostate surgery or radiation therapy, indicating a possible return of cancer.
- Men who are sexually active with women of childbearing age must use effective birth control for 24 hours after the fluciclovine (18F) injection.
- Must agree to participate and sign a consent form.
- Must be able to follow the study procedures.
Exclusion Criteria
- Known metastatic prostate cancer that is resistant to hormone therapy.
- Any medical condition or situation that might affect the study results or the participant's ability to follow the study requirements.
- Planned use of x-ray contrast or other PET tracers close to the study's PET scan.
- Participation in another clinical trial within 30 days before the study's PET scan.
- Allergy to fluciclovine (18F) or its ingredients.
- Have received additional treatment for the current cancer recurrence.
- Started new cancer treatments or supplements between the PSMA PET and fluciclovine (18F) PET/CT scans.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Diego Health | 92103 | San Diego | California |
| Emory University | 30322 | Atlanta | Georgia |
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Washington University | 63110 | St Louis | Missouri |
| Oregon Health & Science University | 97239 | Portland | Oregon |
| Urology Austin | 78759 | Austin | Texas |
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