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.
Additional locations may be listed on ClinicalTrials.gov for NCT05588128.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
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.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorRavi A. Madan
