Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Prostate Cancer · Biochemically Recurrent
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- 18 years - Not specified
- Sex eligible
- Male
- Healthy volunteers
- Not accepted
- Participants
- 350 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
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Read the full 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. Clinical trial treatments are allowable within the 6 months before 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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
- 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. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.
Study population
Primary clinical
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
Cohort 1
Participants with biochemically recurrent prostate cancer
Drug: 18F-DCFpyL
18F-DCFpyL DRUG
Administered to Cohort.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Observation of 18F-DCFPyL lesions in BRPC
Time frame: baseline through 5 years
Initial 18F-DCFPyL imaging, every 6 months (+/- 8 weeks) for participants positive on imaging, and every 12 months (+/- 12 weeks) for participants negative on imaging until 5 years.
Secondary measures
Progression on 18F-DCFPyL
Time frame: baseline through 5 years
Initial 18F-DCFPyL imaging, every 6 months (+/- 8 weeks) for participants positive on imaging, and every 12 months (+/- 12 weeks) for participants negative on imaging until 5 years.
Evaluate PSA doubling in association with 18F-DCFPyL changes
Time frame: baseline through 5 years
PSA test every 3 months (+/- 4 weeks) until 5 years.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesRecruiting
Study team and timeline
- Lead sponsor
- National Cancer Institute (NCI)
- Study start
- Mar 21, 2023 Actual
- Primary completion
- Dec 31, 2026 Estimated
- Study completion
- Dec 31, 2027 Estimated
- First posted
- Oct 20, 2022 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026