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

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: 18F-DCFBC Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer
Study Start Date : December 2011
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496157


Locations
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Steve Y. Cho, MD Johns Hopkins University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01496157     History of Changes
Other Study ID Numbers: J1191
NA_00051395 ( Other Identifier: JHMIRB )
First Posted: December 21, 2011    Key Record Dates
Last Update Posted: June 18, 2014
Last Verified: June 2014

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Primary Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases