This trial is active, not recruiting.

Condition metastatic prostate cancer
Treatment 18f-dcfbc
Phase phase 1/phase 2
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date March 2013
End date January 2015
Trial size 25 participants
Trial identifier NCT01815515, J12113


This research is being done to see if an investigational radioactive drug called 18F-DCFBC can help us find cancer that has spread (metastatic disease) from its original site in people who have cancer in their prostate to other parts of their body.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
18f-dcfbc A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.

Primary Outcomes

PET/CT detection of Metastatic Prostate Cancer
time frame: 24 Months

Secondary Outcomes

Measurement of new or progressive disease
time frame: 24 Months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: 1. Histological confirmation of prostate cancer 2. Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, [18F]Sodium Fluoride PET, and/or [18F]FDG PET 3. Rising PSA on two observations taken at least 1 week apart 4. Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration 5. Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease 6. Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging 7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits 8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures Exclusion Criteria: 1. Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration 2. Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest) 3. Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression. 4. Serum creatinine > 3 times the upper limit of normal 5. Total bilirubin > 3 times the upper limit of normal 6. Liver Transaminases > 5times the upper limit of normal 7. Unable to lie flat during or tolerate PET/CT 8. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Additional Information

Official title Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer.
Principal investigator Steve Y Cho, M.D
Description The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), [18F]DCFBC (DCFBC) PET imaging for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. The investigators propose to assess the ability of DCFBC PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by standard conventional imaging modalities (CIM) for prostate cancer which includes IV contrast CT of chest/abdomen/pelvis and whole body bone scintigraphy.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.