Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01496157
Recruitment Status : Unknown
Verified June 2014 by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
Recruitment status was:  Active, not recruiting
First Posted : December 21, 2011
Last Update Posted : June 18, 2014
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

December 13, 2011
December 21, 2011
June 18, 2014
December 2011
January 2015   (Final data collection date for primary outcome measure)
PET detection of primary prostate cancer [ Time Frame: 24 months ]
To compare the detection and sextant localization of primary prostate cancer by DCFBC PET to prostatectomy pathology as determined by tissue step-section analysis in men with biopsy-positive prostate cancer (Gleason score > 4+3=7).
Same as current
Complete list of historical versions of study NCT01496157 on Archive Site
PET detection of metastatic disease at initial staging [ Time Frame: 24 months ]
To compare the detection of bone and nodal metastatic disease by DCFBC PET at initial staging to detection by available conventional imaging modalities (bone scan, CT, MRI) and biopsy pathology.
Same as current
Not Provided
Not Provided
Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
Evaluation of PSMA-based PET as an Imaging Biomarker of Primary 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), as a PET imaging biomarker of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness but a quantitative non-invasive method for PSMA detection and monitoring is not currently available. Development of such an imaging biomarker would be useful to differentiate indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies. The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators propose to study patients initially diagnosed with biopsy-positive prostate cancer to determine if DCFBC uptake and location by PET imaging will be positively correlated with prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of suspected metastatic disease will be compared to conventional imaging modalities (CT, bone scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be compared with expression levels of PSMA and other prostate cancer relevant markers (PSA, Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived prediction of pathologic stage).
Not Provided
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Prostate Cancer
Drug: 18F-DCFBC
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.
Not Provided
Rowe SP, Gage KL, Faraj SF, Macura KJ, Cornish TC, Gonzalez-Roibon N, Guner G, Munari E, Partin AW, Pavlovich CP, Han M, Carter HB, Bivalacqua TJ, Blackford A, Holt D, Dannals RF, Netto GJ, Lodge MA, Mease RC, Pomper MG, Cho SY. ¹⁸F-DCFBC PET/CT for PSMA-Based Detection and Characterization of Primary Prostate Cancer. J Nucl Med. 2015 Jul;56(7):1003-1010. doi: 10.2967/jnumed.115.154336. Epub 2015 Jun 11.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Newly diagnosed prostate cancer pathologically proven by prostate biopsy
  2. Prostate biopsy histology grade ≥ Gleason 3+3=6.
  3. Patients considered as candidates for and medically fit to undergo prostatectomy
  4. At least 10 days after most recent prostate biopsy
  5. No known problems with peripheral IV or central line access
  6. Able to tolerate urinary straight catheter placement
  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. Prior pelvic external beam radiation therapy or brachytherapy
  2. Chemotherapy for prostate cancer
  3. Hormone deprivation therapy
  4. Investigational therapy for prostate cancer
  5. Hemorrhagic cystitis or active prostatitis
  6. Unable to lie flat during or tolerate PET/CT
  7. 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
  8. No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
  9. Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/min/1.73m2
Sexes Eligible for Study: Male
18 Years to 90 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
NA_00051395 ( Other Identifier: JHMIRB )
Not Provided
Not Provided
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Not Provided
Principal Investigator: Steve Y. Cho, MD Johns Hopkins University
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP