This pilot clinical trial studies how well fluorine F 18 DCFBC positron emission tomography (PET)/computed tomography (CT) works in imaging patients with prostate cancer. PET/CT is a procedure that takes detailed pictures of areas inside the body using a radiotracer called fluorine F 18 DCFBC. Since cancer cells often take up more fluorine F 18 DCFBC than normal cells the pictures may help to identify sites of prostate cancer in the body.
Additional locations may be listed on ClinicalTrials.gov for NCT02190279.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess the ability of 18F-DCFBC (fluorine F 18 DCFBC) to differentiate between tumorous and non-tumorous tissues in localized, recurrent (based on rising prostate-specific antigen [PSA] post treatment) and metastatic prostate cancer.
SECONDARY OBJECTIVES:
I. Compare the distribution 18F-DCFBC with multiparametric magnetic resonance imaging (MRI) and whole mount histopathology in patients undergoing prostatectomy.
II. Evaluate the distribution 18F-DCFBC uptake in prostate cancer patients with biochemical relapse (site of recurrence unknown).
III. Compare focal 18F-DCFBC uptake with focal abnormalities identified on standard of care imaging.
IV. Compare the uptake of 18F-DCFBC in bone with respect to Na18F (fluorine F 18 sodium fluoride) PET/CT in patients with metastatic disease (the emerging gold standard, for detection of bony metastases).
V. Evaluate the change over time in 18F-DCFBC distribution in patients with known metastatic disease with clinical follow-up data 4-6 months post baseline 18F-DCFBC PET/CT (e.g. understand the effect of androgen deprivation therapy [ADT] on 18F-DCFBC uptake).
TERTIARY OBJECTIVES:
I. If PET/MRI is obtained, findings will be compared with other acquired imaging studies.
OUTLINE: Patients are assigned to 1 of 3 arms according to their disease type.
ARM I (LOCALIZED): Patients undergo dynamic and static whole body fluorine F 18 DCFBC PET/CT.
ARM II (RECURRENT): Patients undergo dynamic and static whole body fluorine F 18 DCFBC PET/CT.
ARM III (METASTATIC): Patients undergo static whole body fluorine F 18 DCFBC PET/CT and fluorine F 18 sodium fluoride PET/CT at baseline and then within 4-6 months following initial scans.
In all Arms, patients may undergo additional PET/MR imaging if scheduling allows, and patient does not have any MR incompatible conditions or implants immediately after F18 DCFBC PET/CT.
After completion of study, patients are followed up within 1-3 days and then for 1 year.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationNCI - Center for Cancer Research
Principal InvestigatorM. Liza Lindenberg