Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
NCT ID: NCT05588128
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
350 participants
OBSERVATIONAL
2023-03-21
2027-12-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1
Participants with biochemically recurrent prostate cancer
18F-DCFpyL
Administered to Cohort.
Interventions
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18F-DCFpyL
Administered to Cohort.
Eligibility Criteria
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Inclusion Criteria
* 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
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
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Ravi A Madan, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
Role: primary
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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10000628
Identifier Type: -
Identifier Source: org_study_id
000628-C
Identifier Type: -
Identifier Source: secondary_id