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Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT02523924
Recruitment Status : Completed
First Posted : August 14, 2015
Results First Posted : January 31, 2020
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Adenocarcinoma of the Prostate
Intervention Drug: 18F-DCFPyL
Enrollment 50
Recruitment Details  
Pre-assignment Details 19 patients did not meet inclusion criteria.
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants
63
(45 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
0
   0.0%
Male
31
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
27
  87.1%
More than one race
0
   0.0%
Unknown or Not Reported
4
  12.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 31 participants
31
 100.0%
Months since radical prostatectomy  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 31 participants
30
(4 to 152)
Gleason grade group   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
1
2
   6.5%
2
6
  19.4%
3
13
  41.9%
4
1
   3.2%
5
9
  29.0%
[1]
Measure Description: The Gleason score ranges from 2-10 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)
Pathologic stage  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
pT2
11
  35.5%
pT3a
14
  45.2%
pT3b
6
  19.4%
Positive surgical margin  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
13
  41.9%
Prostate Specific Antigen (PSA)  
Median (Full Range)
Unit of measure:  ng/mL
Number Analyzed 31 participants
0.4
(0.2 to 28.3)
1.Primary Outcome
Title Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Hide Description Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description:

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
at least 1 site
21
  67.7%
> 1 site
5
  16.1%
no sites
5
  16.1%
2.Primary Outcome
Title Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Hide Description Location of uptake of 18F-DCFPyL consistent with prostate cancer.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Location of 18F-DCFPyL uptake could only be assessed in patients with at least 1 site of 18F-DCFPyL uptake (26/31)
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description:

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

Overall Number of Participants Analyzed 26
Measure Type: Count of Participants
Unit of Measure: Participants
Prostate bed
8
  30.8%
Pelvic lymph node
14
  53.8%
Nonpelvic lymph node
2
   7.7%
Bone
2
   7.7%
Viscera
0
   0.0%
3.Secondary Outcome
Title Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
Hide Description Number of participants with PSA 0.2-1.0ng/mL OR PSA >1.0ng/mL with at least 1 site of uptake of 18F-DCFPyL consistent with prostate cancer.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Only 22/31 participants had a PSA of 0.2-1.0ng/mL and 9/31 participants had PSA >1.0ng/mL.
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description:

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

Overall Number of Participants Analyzed 31
Measure Type: Count of Participants
Unit of Measure: Participants
PSA 0.2-1.0 ng/mL Number Analyzed 22 participants
13
  59.1%
PSA >1.0 ng/mL Number Analyzed 9 participants
8
  88.9%
4.Secondary Outcome
Title Correlation of Findings on 18FDCFPyL PET/CT With Those Found on Conventional Imaging (Bone Scan and Cross-sectional Imaging)
Hide Description Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome as participants did not have conventional imaging correlates.
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description:

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Correlation of Findings on 18F-DCFPyL PET/CT With Tissue Histology and PSMA Expression of Biopsied/Resected Pathology Specimens
Hide Description Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected to assess this outcome measure as confirmatory biopsy was not practical to perform and histopathologic confirmation is not available.
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description:

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Other Pre-specified Outcome
Title Correlation of 18F-DCFPyL PET/CT Findings With Time to Disease Progression
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Assessment of Treatment Response by 18F-DCFPyL PET/CT
Hide Description [Not Specified]
Time Frame 6 months
Outcome Measure Data Not Reported
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 18F-DCFPyL PET/CT
Hide Arm/Group Description

Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT

18F-DCFPyL: 18F-DCFPyL PET/CT

All-Cause Mortality
18F-DCFPyL PET/CT
Affected / at Risk (%)
Total   0/31 (0.00%) 
Hide Serious Adverse Events
18F-DCFPyL PET/CT
Affected / at Risk (%)
Total   0/31 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
18F-DCFPyL PET/CT
Affected / at Risk (%)
Total   0/31 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Steven Rowe, MD
Organization: Johns Hopkins University
Phone: 4105028052
EMail: srowe8@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02523924    
Other Study ID Numbers: J1545
IRB00062296 ( Other Identifier: JHMIRB )
First Submitted: May 28, 2015
First Posted: August 14, 2015
Results First Submitted: January 22, 2020
Results First Posted: January 31, 2020
Last Update Posted: January 31, 2020