Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Background:
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Prostate cancer is the most common malignancy and the second leading cause of cancer- related deaths in American men.
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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).
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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.
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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:
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History of primary treatment for prostate cancer (either surgery or radiation).
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PSA >= 0.50, and testosterone >100.
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Age >= 18 years.
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No evidence of metastatic soft tissue disease on CT scan (or MRI), or bone lesions on bone scan.
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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:
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Eligible participants will have clinical evaluations and imaging studies. Participants with negative findings on initial/following 18F-DCFPyL scan(s) will be invited every year (+/-2 months) for follow-up imaging studies (including 18F-DCFPyL PET scans). Participants with positive findings on initial/following 18F-DCFPyL scan(s) will be invited every 6 (+/- 1) months for repeat scans, not to exceed 2 scans per year.
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After the initial evaluation, participants will be invited to NIH every 3 months (+/- 2 weeks) for PSA testing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cohort 1 Participants with biochemically recurrent prostate cancer |
Drug: 18F-DCFpyL
Administered to Cohort.
|
Outcome Measures
Primary Outcome Measures
- Observation of 18F-DCFPyL lesions in BRPC [baseline through 5 years]
Initial 18F-DCFPyL imaging, every 6 months (+/-2 weeks) for participants positive on imaging, and every 12 months (+/- 2 months) for participants negative on imaging until 5 years.
Secondary Outcome Measures
- Progression on 18F-DCFPyL [baseline through 5 years]
Initial 18F-DCFPyL imaging, every 6 months (+/-2 weeks) for participants positive on imaging, and every 12 months (+/- 2 months) for participants negative on imaging until 5 years.
- Evaluate PSA doubling in association with 18F-DCFPyL changes [baseline through 5 years]
PSA test every 3 months (+/- 2 weeks) until 5 years.
Eligibility Criteria
Criteria
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INCLUSION CRITERIA:
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History of primary treatment for prostate cancer (either surgery or radiation)
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Serum PSA >= 0.50
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Serum testosterone >100
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Age >=18 years
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Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexualsexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable
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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.
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Evidence of bone lesions on Tc99 bone scan
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Prostatectomy within 1 year before the study intervention
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Androgen deprivation therapy (ADT) within the 6 months before the study intervention
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Systemic therapy for prostate cancer within the 6 months before the study intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ravi A Madan, M.D., National Cancer Institute (NCI)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 10000628
- 000628-C