Trial Outcomes & Findings for Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy (NCT NCT02523924)
NCT ID: NCT02523924
Last Updated: 2020-01-31
Results Overview
Number of sites with 18F-DCFPyL uptake consistent with prostate cancer.
COMPLETED
NA
50 participants
6 months
2020-01-31
Participant Flow
19 patients did not meet inclusion criteria.
Participant milestones
| Measure |
18F-DCFPyL PET/CT
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
18F-DCFPyL: 18F-DCFPyL PET/CT
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
18F-DCFPyL PET/CT
n=31 Participants
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
18F-DCFPyL: 18F-DCFPyL PET/CT
|
|---|---|
|
Age, Continuous
|
63 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
|
Months since radical prostatectomy
|
30 months
n=5 Participants
|
|
Gleason grade group
1
|
2 Participants
n=5 Participants
|
|
Gleason grade group
2
|
6 Participants
n=5 Participants
|
|
Gleason grade group
3
|
13 Participants
n=5 Participants
|
|
Gleason grade group
4
|
1 Participants
n=5 Participants
|
|
Gleason grade group
5
|
9 Participants
n=5 Participants
|
|
Pathologic stage
pT2
|
11 Participants
n=5 Participants
|
|
Pathologic stage
pT3a
|
14 Participants
n=5 Participants
|
|
Pathologic stage
pT3b
|
6 Participants
n=5 Participants
|
|
Positive surgical margin
|
13 Participants
n=5 Participants
|
|
Prostate Specific Antigen (PSA)
|
0.4 ng/mL
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsNumber of sites with 18F-DCFPyL uptake consistent with prostate cancer.
Outcome measures
| Measure |
18F-DCFPyL PET/CT
n=31 Participants
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
18F-DCFPyL: 18F-DCFPyL PET/CT
|
|---|---|
|
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
at least 1 site
|
21 Participants
|
|
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
> 1 site
|
5 Participants
|
|
Number of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
no sites
|
5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Location of 18F-DCFPyL uptake could only be assessed in patients with at least 1 site of 18F-DCFPyL uptake (26/31)
Location of uptake of 18F-DCFPyL consistent with prostate cancer.
Outcome measures
| Measure |
18F-DCFPyL PET/CT
n=26 Participants
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
18F-DCFPyL: 18F-DCFPyL PET/CT
|
|---|---|
|
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Prostate bed
|
8 Participants
|
|
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Pelvic lymph node
|
14 Participants
|
|
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Nonpelvic lymph node
|
2 Participants
|
|
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Bone
|
2 Participants
|
|
Location of Putative Sites of Metastatic Disease as Determined by 18F-DCFPyL PET/CT
Viscera
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only 22/31 participants had a PSA of 0.2-1.0ng/mL and 9/31 participants had PSA \>1.0ng/mL.
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.
Outcome measures
| Measure |
18F-DCFPyL PET/CT
n=31 Participants
Men with an elevated PSA following radical prostatectomy imaged with 18F-DCFPyL PET/CT
18F-DCFPyL: 18F-DCFPyL PET/CT
|
|---|---|
|
Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
PSA 0.2-1.0 ng/mL
|
13 Participants
|
|
Correlation of 18F-DCFPyL PET/CT Findings With Prostate Specific Antigen (PSA) Levels
PSA >1.0 ng/mL
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was not collected for this outcome as participants did not have conventional imaging correlates.
Number of sites with uptake on 18F-DCFPyL PET/CT and corresponding lesions identified on conventional imaging.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data was not collected to assess this outcome measure as confirmatory biopsy was not practical to perform and histopathologic confirmation is not available.
Number of sites with 18F-DCFPyL uptake from which biopsy specimens show PSMA expression.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsOutcome measures
Outcome data not reported
Adverse Events
18F-DCFPyL PET/CT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place