Status:
COMPLETED
Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Conditions:
Metastatic Prostate Cancer
Eligibility:
MALE
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed 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...
Eligibility Criteria
Inclusion
- Histological confirmation of prostate cancer
- 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
- Rising PSA on two observations taken at least 1 week apart
- Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
- Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
- Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
- 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
- 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
- Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
- 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)
- Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
- Serum creatinine \> 3 times the upper limit of normal
- Total bilirubin \> 3 times the upper limit of normal
- Liver Transaminases \> 5times the upper limit of normal
- Unable to lie flat during or tolerate PET/CT
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2015
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01815515
Start Date
March 1 2013
End Date
November 18 2015
Last Update
August 20 2018
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287