Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: March 18, 2013
Last updated: June 16, 2014
Last verified: June 2014

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.

Condition Intervention Phase
Metastatic Prostate Cancer
Drug: 18F-DCFBC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of 18F-DCFBC PSMA-based PET Imaging for Detection of Metastatic Prostate Cancer.

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • PET/CT detection of Metastatic Prostate Cancer [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    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..

Secondary Outcome Measures:
  • Measurement of new or progressive disease [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    Estimate the proportion of new or progressive metastatic lesions found on conventional imaging modalities (CIM) that are DCFBC PET positive. Estimate the proportion of DCFBC PET positive sites that are positive for new or progressive metastatic disease by conventional imaging modalities (CIM) for prostate cancer.

Estimated Enrollment: 25
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 18F-DCFBC Drug: 18F-DCFBC
Other Name: A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.

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 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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 administration
  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 the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01815515

United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Principal Investigator: Steve Y Cho, M.D Johns Hopkins University
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center Identifier: NCT01815515     History of Changes
Other Study ID Numbers: J12113
Study First Received: March 18, 2013
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
Metastatic Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on March 03, 2015