Trial Outcomes & Findings for 68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer (NCT NCT05547386)
NCT ID: NCT05547386
Last Updated: 2025-07-18
Results Overview
Safety of gallium Ga 68 gozetotide \[68Ga-prostate-specific membrane antigen (PSMA)-11\] assessed by the number of patients reporting unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11.
COMPLETED
PHASE3
163 participants
From the time of injection until the time after imaging scan is complete, up to 1 day
2025-07-18
Participant Flow
Participant milestones
| Measure |
Observational (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Computed Tomography: Undergo PET/CT scan
Gallium Ga 68 Gozetotide: Given IV
Positron Emission Tomography: Undergo PET/CT scan
|
|---|---|
|
Overall Study
STARTED
|
163
|
|
Overall Study
COMPLETED
|
156
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Observational (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Computed Tomography: Undergo PET/CT scan
Gallium Ga 68 Gozetotide: Given IV
Positron Emission Tomography: Undergo PET/CT scan
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Observational (68Ga-PSMA-11 PET/CT)
n=163 Participants
Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Computed Tomography: Undergo PET/CT scan
Gallium Ga 68 Gozetotide: Given IV
Positron Emission Tomography: Undergo PET/CT scan
|
|---|---|
|
Age, Customized
30-39
|
1 Participants
n=163 Participants
|
|
Age, Customized
40-49
|
1 Participants
n=163 Participants
|
|
Age, Customized
50-59
|
9 Participants
n=163 Participants
|
|
Age, Customized
60-69
|
63 Participants
n=163 Participants
|
|
Age, Customized
70-79
|
69 Participants
n=163 Participants
|
|
Age, Customized
80-89
|
18 Participants
n=163 Participants
|
|
Age, Customized
90-99
|
2 Participants
n=163 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=163 Participants
|
|
Sex: Female, Male
Male
|
163 Participants
n=163 Participants
|
|
Region of Enrollment
United States
|
163 participants
n=163 Participants
|
PRIMARY outcome
Timeframe: From the time of injection until the time after imaging scan is complete, up to 1 daySafety of gallium Ga 68 gozetotide \[68Ga-prostate-specific membrane antigen (PSMA)-11\] assessed by the number of patients reporting unexpected adverse reactions from the time of injection until the time they leave the care of the division of nuclear medicine. If any adverse reactions are reported, the patient will be evaluated by a nurse and/or physician and will receive appropriate care. The principal investigator (PI) or those designated by the PI will ascertain the severity of the adverse event and how likely the adverse reaction was associated with the injected 68Ga-PSMA-11.
Outcome measures
| Measure |
Observational (68Ga-PSMA-11 PET/CT)
n=156 Participants
Patients receive 68Ga-PSMA-11 IV and then undergo a PSMA PET/CT scan throughout the trial.
Computed Tomography: Undergo PET/CT scan
Gallium Ga 68 Gozetotide: Given IV
Positron Emission Tomography: Undergo PET/CT scan
|
|---|---|
|
Patients Reporting Adverse Reactions
|
0 Participants
|
Adverse Events
Observational (68Ga-PSMA-11 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