PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
Sponsor: AdventHealth
ClinicalTrials ID:NCT06617481
This study is exploring the use of a special PET scan, called flotufolastat F-18, to detect prostate cancer in men who have low levels of PSA after prostate surgery.
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Program Overview
The study is investigating how well a PET scan using flotufolastat F-18 can find prostate cancer in men who have low levels of Prostate-Specific Antigen (PSA) after having surgery to remove the prostate. This scan is already approved by the FDA for use in detecting prostate cancer that may have spread or returned.
Description
This study is not testing a new drug. The flotufolastat PET scan is already approved by the FDA for use in men with prostate cancer. It helps to find cancer that may have spread or come back, especially when PSA levels are rising. In this study, if the first scan does not show cancer and PSA levels continue to rise by more than 0.1 ng/ml, the scan will be repeated. This is because other scans might not detect cancer in patients with low but increasing PSA levels.
Eligibility Criteria
Inclusion Criteria
- Have a history of prostate cancer that was treated with surgery intended to cure it.
- Have a PSA test result that is 0.1 ng/ml or higher but less than 0.5 ng/ml.
Exclusion Criteria
- Planning to have an x-ray contrast agent or another PET scan less than 24 hours before the flotufolastat F-18 PET scan.
- Currently receiving Androgen Deprivation Therapy (ADT).
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