Trial Outcomes & Findings for 68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy (NCT NCT03949517)
NCT ID: NCT03949517
Last Updated: 2024-01-30
Results Overview
Positron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Up to approximately 2 hours to complete each scan
Results posted on
2024-01-30
Participant Flow
Participant milestones
| Measure |
68-Ga PSMA11+68-Ga RM2
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks, then receive high-intensity focused ultrasound (HIFU). Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
|
68-Ga RM2+68-Ga PSMA11
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks, then receive HIFU. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
|
|---|---|---|
|
Pre-HIFU Period, Imaging Timepoint 1
STARTED
|
7
|
7
|
|
Pre-HIFU Period, Imaging Timepoint 1
COMPLETED
|
7
|
7
|
|
Pre-HIFU Period, Imaging Timepoint 1
NOT COMPLETED
|
0
|
0
|
|
Pre-HIFU Period, Imaging Timepoint 2
STARTED
|
7
|
7
|
|
Pre-HIFU Period, Imaging Timepoint 2
COMPLETED
|
7
|
7
|
|
Pre-HIFU Period, Imaging Timepoint 2
NOT COMPLETED
|
0
|
0
|
|
HIFU Treatment
STARTED
|
7
|
7
|
|
HIFU Treatment
COMPLETED
|
7
|
7
|
|
HIFU Treatment
NOT COMPLETED
|
0
|
0
|
|
Post-HIFU Period, Imaging Timepoint 1
STARTED
|
7
|
7
|
|
Post-HIFU Period, Imaging Timepoint 1
COMPLETED
|
7
|
7
|
|
Post-HIFU Period, Imaging Timepoint 1
NOT COMPLETED
|
0
|
0
|
|
Post-HIFU Period, Imaging Timepoint 2
STARTED
|
7
|
7
|
|
Post-HIFU Period, Imaging Timepoint 2
COMPLETED
|
7
|
7
|
|
Post-HIFU Period, Imaging Timepoint 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
68-Ga PSMA 11 PET/MRI and 68-Ga RM2 PET/MRI for Evaluation of Prostate Cancer Response to HIFU Therapy
Baseline characteristics by cohort
| Measure |
68-Ga PSMA11+68-Ga RM2
n=7 Participants
68-Ga PSMA11 first followed by 68-Ga RM2 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
|
68-Ga RM2+68-Ga PSMA11
n=7 Participants
68-Ga RM2 first followed by 68-Ga PSMA11 within 2 weeks. Participant will be injected IV with 140 ± 20% mBq of 68-Ga RM2 OR 3 to 7 mCi of 68-Ga PSMA11
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
63.9 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
64.5 years
STANDARD_DEVIATION 8.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 hours to complete each scanPositron emission tomography (PET) based of Assessment of Local Therapeutic Response. Therapeutic response to HIFU will be assessed by 68-Ga PSMA 11 and 68-Ga RM2 PET scans.
Outcome measures
| Measure |
68-Ga PSMA11
n=14 Participants
68-Ga PSMA11 scan before and after HIFU
|
68-Ga RM2
n=14 Participants
68-Ga RM2 scan before and after HIFU
|
|---|---|---|
|
Number of Participants for Which an Assessment of PET Based Therapeutic Response to HIFU is Successfully Obtained
|
14 Participants
|
14 Participants
|
Adverse Events
68-Ga PSMA11
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
68-Ga RM2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place