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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 : Completed
First Posted : December 21, 2011
Results First Posted : August 28, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Drug: 18F-DCFBC
Enrollment 15
Recruitment Details  
Pre-assignment Details 2 enrolled participants were screen failures, therefore 13 started the study.
Arm/Group Title Patients With Primary Prostate Cancer
Hide Arm/Group Description

Patients will be imaged with 18F-DCFBC

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.

Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Patients With Primary Prostate Cancer
Hide Arm/Group Description

Patients will be imaged with 18F-DCFBC

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.

Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  69.2%
>=65 years
4
  30.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
0
   0.0%
Male
13
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
Prostate specific antigen (PSA)  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 13 participants
8.36  (3.77)
Biopsy Gleason Score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Gleason score 3+3 Number Analyzed 13 participants
1
   7.7%
Gleason Score 3+4 Number Analyzed 13 participants
5
  38.5%
Gleason Score 4+3 Number Analyzed 13 participants
4
  30.8%
Gleason Score 4+4 Number Analyzed 13 participants
3
  23.1%
[1]
Measure Description: The Gleason score is an indication of prognosis based on prostate pathology. The total score ranges from 2 to 10 (ie: "1+1" to "5+5") with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5).
Prostatectomy gleason score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Gleason 3+3 Number Analyzed 13 participants
1
   7.7%
Gleason 3+4 Number Analyzed 13 participants
5
  38.5%
Gleason 4+3 Number Analyzed 13 participants
2
  15.4%
Gleason 4+4 Number Analyzed 13 participants
1
   7.7%
Gleason 4+5 Number Analyzed 13 participants
3
  23.1%
Gleason 5+3 Number Analyzed 13 participants
1
   7.7%
[1]
Measure Description: The Gleason score is an indication of prognosis based on prostate pathology. The total score ranges from 2 to 10 (ie: "1+1" to "5+5") with a higher score reflecting less-differentiated tumors with worse prognosis. The total score is a sum of two numbers which are based on the microscopic appearance of cells. The first number is the score based on the dominant, cell morphology (scored 1-5) and the second number is based on the highest grade of the non-dominant cell pattern (scored 1-5).
1.Primary Outcome
Title PET Detection of Primary Prostate Cancer
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Patients With Primary Prostate Cancer
Hide Arm/Group Description:

Patients will be imaged with 18F-DCFBC

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.

Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Prostate Cancer with Positive Uptake of 18F-DCFBC
6
  46.2%
Prostate Cancer with Negative Uptake of 18F-DCFBC
7
  53.8%
2.Secondary Outcome
Title PET Detection of Metastatic Disease at Initial Staging
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure.
Arm/Group Title Patients With Primary Prostate Cancer
Hide Arm/Group Description:

Patients will be imaged with 18F-DCFBC

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.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Patients With Primary Prostate Cancer
Hide Arm/Group Description

Patients will be imaged with 18F-DCFBC

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.

All-Cause Mortality
Patients With Primary Prostate Cancer
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Patients With Primary Prostate Cancer
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Patients With Primary Prostate Cancer
Affected / at Risk (%)
Total   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Rowe, M.D, Ph.D
Organization: Johns Hopkins University
Phone: 4105021520
EMail: srowe8@jhmi.edu
Layout table for additonal information
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 Submitted: December 13, 2011
First Posted: December 21, 2011
Results First Submitted: August 2, 2016
Results First Posted: August 28, 2018
Last Update Posted: August 28, 2018