Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-DCFBC
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Primary Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Newly diagnosed prostate cancer pathologically proven by prostate biopsy
- Prostate biopsy histology grade ≥ Gleason 3+3=6.
- Patients considered as candidates for and medically fit to undergo prostatectomy
- At least 10 days after most recent prostate biopsy
- No known problems with peripheral IV or central line access
- Able to tolerate urinary straight catheter placement
- 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.
- 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:
- Prior pelvic external beam radiation therapy or brachytherapy
- Chemotherapy for prostate cancer
- Hormone deprivation therapy
- Investigational therapy for prostate cancer
- Hemorrhagic cystitis or active prostatitis
- Unable to lie flat during or tolerate PET/CT
- 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
- No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
- Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/min/1.73m2
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Primary Prostate Cancer
Arm Description
Patients will be imaged with 18F-DCFBC
Outcomes
Primary Outcome Measures
PET Detection of Primary Prostate Cancer
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).
Secondary Outcome Measures
PET Detection of Metastatic Disease at Initial Staging
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.
Full Information
NCT ID
NCT01496157
First Posted
December 13, 2011
Last Updated
July 31, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1. Study Identification
Unique Protocol Identification Number
NCT01496157
Brief Title
Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
Official Title
Evaluation of PSMA-based PET as an Imaging Biomarker of Primary Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 11, 2012 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
September 17, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Primary Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Primary Prostate Cancer
Arm Type
Experimental
Arm Description
Patients will be imaged with 18F-DCFBC
Intervention Type
Drug
Intervention Name(s)
18F-DCFBC
Intervention Description
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 Measure Information:
Title
PET Detection of Primary Prostate Cancer
Description
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).
Time Frame
24 months
Secondary Outcome Measure Information:
Title
PET Detection of Metastatic Disease at Initial Staging
Description
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.
Time Frame
24 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newly diagnosed prostate cancer pathologically proven by prostate biopsy
Prostate biopsy histology grade ≥ Gleason 3+3=6.
Patients considered as candidates for and medically fit to undergo prostatectomy
At least 10 days after most recent prostate biopsy
No known problems with peripheral IV or central line access
Able to tolerate urinary straight catheter placement
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.
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:
Prior pelvic external beam radiation therapy or brachytherapy
Chemotherapy for prostate cancer
Hormone deprivation therapy
Investigational therapy for prostate cancer
Hemorrhagic cystitis or active prostatitis
Unable to lie flat during or tolerate PET/CT
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
No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
Serum creatinine > 1.5 mg/dL or creatinine clearance < 50 mL/min/1.73m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Rowe, MD, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26069305
Citation
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. (1)(8)F-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.
Results Reference
derived
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Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer
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