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

July 31, 2018 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with Primary Prostate Cancer
Patients will be imaged with 18F-DCFBC
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET Detection of Primary Prostate Cancer
Time Frame: 24 months
To compare number of participants with positive or negative uptake of 18F-DCFBC in 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).
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Investigators

  • Principal Investigator: Steven P Rowe, MD, PhD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

September 17, 2017

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 21, 2011

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

July 31, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1191
  • NA_00051395 (Other Identifier: JHMIRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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