Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL

Summary

Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer. Objective: To learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer. Eligibility: Men aged 18 and older with prostate cancer that returned after treatment. Design: Participants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis. Participants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes. Participants will return for blood tests every 3 months. Participants will return for additional scans with 18F-DCFPyL on this schedule: Once a year if their previous scan was negative for prostate cancer. Every 6 months if their previous scan was positive for prostate cancer. Participants may be in the study up to 5 years. ...

Eligibility

* INCLUSION CRITERIA:
* History of primary treatment for prostate cancer (either surgery or radiation)
* Serum PSA \>= 0.50
* Serum testosterone \>100
* Age \>=18 years
* Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable
* The ability of a participant to understand and the willingness to sign a written informed consent document

EXCLUSION CRITERIA:

-Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \[MRI\] as clinically indicated).

NOTE: Lymph nodes \<= 1.5 cm in the shortest dimension are allowed.

* Evidence of bone lesions on Tc99 bone scan
* Prostatectomy within 1 year before the study intervention
* Androgen deprivation therapy (ADT) within the 6 months before the study intervention
* Systemic therapy for prostate cancer within the 6 months before the study intervention

Conditions3

Locations1 site

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