RecruitingNCT05588128

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

A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL


Sponsor

National Cancer Institute (NCI)

Enrollment

350 participants

Start Date

Mar 21, 2023

Study Type

OBSERVATIONAL

Conditions

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how prostate cancer behaves after initial treatment using a specialized PET scan called 18F-DCFPyL, which can detect prostate cancer cells throughout the body. It is for men whose PSA (a blood marker for prostate cancer) has risen again after surgery or radiation, suggesting the cancer may be returning. **You may be eligible if...** - You have previously been treated for prostate cancer with surgery or radiation - Your PSA level is 0.50 or higher - Your testosterone level is above 100 - You are 18 years or older **You may NOT be eligible if...** - You have evidence of conditions that would make this imaging or study participation unsafe (as determined by the study team) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-DCFpyL

Administered to Cohort.


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT05588128


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