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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Prostate Cancer

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Trial Information

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

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.

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

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 last 2 years, other than skin basal cell
carcinoma or superficial bladder cancer.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

PET/CT detection of Metastatic Prostate Cancer

Outcome Description:

To compare the diagnostic accuracy of DCFBC PET to CIM (CT and bone scintigraphy) for detection of metastatic prostate cancer based on comparison to dynamic CIM incorporating prior and follow-up scans..

Outcome Time Frame:

24 Months

Safety Issue:


Principal Investigator

Steve Y Cho, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2013

Completion Date:

January 2015

Related Keywords:

  • Metastatic Prostate Cancer
  • Metastatic Prostate Cancer
  • Prostatic Neoplasms



Johns Hopkins University Baltimore, Maryland  21205