Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

Study Overview
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Brief Summary
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This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.

Detailed Description
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To assess the hypothesis that this new 2nd generation positron emission tomography (PET) radiopharmaceutical, 18F-DCFPyL, may possess pharmacokinetic and pharmacodynamic properties that will represent an advance in imaging metastatic prostate cancer in ten patients diagnosed with metastatic prostate cancer.

Official Title
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Study of 18F-DCFPyL, a Second Generation Low-molecular Weight PSMA-based PET Radiotracer, in Patients With Prostate Cancer

Conditions
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Metastatic Prostate Cancer

Intervention / Treatment
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* Drug: 18F-DCFPyL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 18F-DCFPyL<br> | Drug: 18F-DCFPyL<br> <br> * Other names: 10.0 A bolus of less than or equal to 9 mCi (331 MBq) of 18F-DCFPyL will be injected into the IV line by slow push IV push.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PET/CT Detection of Metastatic Disease | To comare diagnostic accuracy of 18-DCFPyL to CIM(CT and bone scintigraphy) for the detection of metastatic prostate cancer. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Prostate Cancer