Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Purpose
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.
Conditions
- Prostate Cancer
- Biochemically Recurrent
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Male
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cohort 1 | Participants with biochemically recurrent prostate cancer |
|
Recruiting Locations
Bethesda, Maryland 20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937
More Details
- NCT ID
- NCT05588128
- Status
- Recruiting
- Sponsor
- National Cancer Institute (NCI)
Detailed Description
Background: - Prostate cancer is the most common malignancy and the second leading cause of cancer-related deaths in American men. - About 25,000 to 50,000 men each year develop a rising prostate-specific antigen (PSA) after definitive radiation or surgery for early-stage disease but have negative findings on computed tomography (CT) and Tc99 bone scan (standard imaging in prostate cancer). - The recent Food and Drug Administration (FDA) approval of 18F-DCFPyL PET imaging provides an opportunity to locate micrometastatic lesions in patients with recurrent disease. - It is unknown how these lesions (or prostate cancer) evolve over time in men with positive findings on 18F-DCFPyL PET imaging. Objective: -To observe participants with biochemically recurrent prostate cancer for 5 years to understand the evolution of 18F-DCFPyL PET lesions in this population. Eligibility: - History of primary treatment for prostate cancer (either surgery or radiation). - PSA >= 0.50, and testosterone >100. - Age >=18 years. - No evidence of metastatic soft tissue disease on CT scan (or MRI), or bone lesions on bone scan. - No androgen deprivation therapy (ADT), no systemic therapy within the 6 months before the study intervention, and no prostatectomy within 1 year before the study intervention. Design: - Eligible participants will have clinical evaluations and imaging studies. Participants with negative findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every year (+/-12 weeks) for follow-up imaging studies (including 18F-DCFPyL PET scans). Participants with positive findings on initial/following 18F-DCFPyL scan(s) will be invited approximately every 6 months (+/-8 weeks) for repeat scans, not to exceed 2 scans per year. - After the initial evaluation, participants will be invited to NIH approximately every 3 months (+/- 4 weeks) for PSA testing.