Status:
COMPLETED
Biodistribution and Pharmacokinetic Study of 18F-DCFBC Prostate Specific Membrane Antigen Based PET in Patients With Advanced Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Prostate Cancer Foundation
Radiological Society of North America
Conditions:
Prostate Cancer
Eligibility:
MALE
18-90 years
Phase:
PHASE1
Brief Summary
Prostate cancer is the most common cancer among men in the United States. Through early detection and improved local therapies a large number of men will be cured. The clinical needs include early det...
Detailed Description
Prostate cancer is the most common cancer among men in the United States. Through early detection and improved local therapies a large number of men will be cured. The clinical needs include early det...
Eligibility Criteria
Inclusion
- Patients may be enrolled into this protocol only if all of the following inclusion criteria are met:
- Greater than or equal to 18 years of age
- 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, or 18F-FDG PET
- PSA ≥ 1.0 ng/mL
- Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
- Platelet count \> 50,000/mm3
- Neutrophil count \> 1,000/mm3
- 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
- Patients will be excluded from enrollment if any of the following apply:
- Karnovsky performance status of \< 60
- Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
- Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
- Administered a radioisotope within 5 physical half-lives prior to study enrollment
- 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
- Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
- Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).
- Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01417182
Start Date
September 1 2010
End Date
September 1 2014
Last Update
January 17 2019
Active Locations (1)
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1
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21227