Prostate Cancer Clinical Trial

Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer

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 in their prostate to other parts of their body.

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT01815515

Recruitment Status:

Completed

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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There is 1 Location for this study

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Johns Hopkins University
Baltimore Maryland, 21287, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 1

Estimated Enrollment:

22

Study ID:

NCT01815515

Recruitment Status:

Completed

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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