This study is currently recruiting participants.
Number
000628-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male Min Age: 18 Years Max Age: N/A
Referral Letter Required
No
Population Exclusion(s)
Female;Children
Keywords
Cancer Of Prostate; Natural History; Imaging
Recruitment Keyword(s)
None
Condition(s)
Prostate Cancer; Biochemically Recurrent
Investigational Drug(s)
18F-DCFpyL
Investigational Device(s)
Intervention(s)
Drug: 18F-DCFpyL
Supporting Site
National Cancer Institute
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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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
-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
Principal Investigator
Referral Contact
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