Trial Outcomes & Findings for PET Imaging in MCI Following ADT for PCa (NCT NCT02061345)
NCT ID: NCT02061345
Last Updated: 2023-12-07
Results Overview
The outcome measure is the increased uptake of 11-Carbon Peripheral Benzodiazepine Receptor-28 (\[11C\]PBR28) biomarker by activated microglia of patients demonstrating significant MCI with the primary endpoint of \[11C\]PBR28 uptake measured as a standardized uptake value (SUV)
COMPLETED
11 participants
Single time-point SUV in Hippocampus area on the day of the test
2023-12-07
Participant Flow
Participant milestones
| Measure |
Mild Cognitive Impairment MCI
Prostate cancer patients having mild cognitive impairment (MCI) attributable to ADT with LHRHa
|
Control
Prostate cancer patients on ADT with LHRHa not having mild cognitive impairment
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
|
Overall Study
COMPLETED
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mild Cognitive Impairment MCI
n=6 Participants
Prostate cancer patients having mild cognitive impairment (MCI) attributable to ADT with LHRHa
|
Control
n=5 Participants
Prostate cancer patients on ADT with LHRHa not having mild cognitive impairment
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=6 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=6 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=6 Participants
|
5 participants
n=5 Participants
|
11 participants
n=11 Participants
|
PRIMARY outcome
Timeframe: Single time-point SUV in Hippocampus area on the day of the testThe outcome measure is the increased uptake of 11-Carbon Peripheral Benzodiazepine Receptor-28 (\[11C\]PBR28) biomarker by activated microglia of patients demonstrating significant MCI with the primary endpoint of \[11C\]PBR28 uptake measured as a standardized uptake value (SUV)
Outcome measures
| Measure |
Mild Cognitive Impairment MCI
n=6 Participants
Prostate cancer patients having mild cognitive impairment (MCI) attributable to ADT with LHRHa
|
Control
n=5 Participants
Prostate cancer patients on ADT with LHRHa not having mild cognitive impairment
|
|---|---|---|
|
PET Biomarker Uptake
|
0.95 Standard Uptake Measure SUV
Standard Deviation 0.25
|
0.98 Standard Uptake Measure SUV
Standard Deviation 0.18
|
SECONDARY outcome
Timeframe: Single time-pointPopulation: Data not collected
Secondary endpoint is the \[11C\]PBR28 total volume of distribution (VT)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Single time-pointPopulation: Data not collected
Association of cognitive and neuropsychiatric impairments following ADT with structural and/or functional brain connectivity
Outcome measures
Outcome data not reported
Adverse Events
Mild Cognitive Impairment MCI
Control
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