Trial Outcomes & Findings for 18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer (NCT NCT04390880)
NCT ID: NCT04390880
Last Updated: 2025-05-16
Results Overview
the percentage of patients whose management was changed after PSMA PET/CT
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
239 participants
Primary outcome timeframe
6 months
Results posted on
2025-05-16
Participant Flow
Participant milestones
| Measure |
PET/CT Arm
Subjects receive a PET/CT scan.
18F-DCFPyL: Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
|
|---|---|
|
Overall Study
STARTED
|
239
|
|
Overall Study
COMPLETED
|
238
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
PET/CT Arm
Subjects receive a PET/CT scan.
18F-DCFPyL: Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
18F-DCFPyL PET/CT Impact on Treatment Strategies for Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
PET/CT Arm
n=239 Participants
Subjects receive a PET/CT scan.
18F-DCFPyL: Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
206 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 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
|
86 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
239 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsthe percentage of patients whose management was changed after PSMA PET/CT
Outcome measures
| Measure |
PET/CT Arm
n=74 Participants
Subjects receive a PET/CT scan.
18F-DCFPyL: Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
|
|---|---|
|
PRIMARY OBJECTIVES: I. To Determine the Impact of 18F-DCFPyL PET/CT on Initial and Subsequent Treatment Strategies of Patients With Prostate Cancer.
|
66.2 Percent
|
Adverse Events
PET/CT Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Gholam Berenji, M.D.
VA Greater Los Angeles Healthcare System
Phone: 310-268-3547
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place