Trial Outcomes & Findings for Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer (NCT NCT00928174)
NCT ID: NCT00928174
Last Updated: 2015-11-11
Results Overview
The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.
COMPLETED
PHASE1/PHASE2
27 participants
Concurrent with PET Procedure
2015-11-11
Participant Flow
Participant milestones
| Measure |
Single Arm
Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Measurement of Anti-Androgen Response Using Fluorine-18 Fluorocholine PET/CT in Androgen-Insensitive Prostate Cancer
Baseline characteristics by cohort
| Measure |
Single Arm
n=27 Participants
Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
|
|---|---|
|
Age, Customized
<40
|
0 participants
n=99 Participants
|
|
Age, Customized
40-49 years
|
0 participants
n=99 Participants
|
|
Age, Customized
50-59 years
|
1 participants
n=99 Participants
|
|
Age, Customized
60-69 years
|
9 participants
n=99 Participants
|
|
Age, Customized
70-79 years
|
4 participants
n=99 Participants
|
|
Age, Customized
80-89 years
|
13 participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Concurrent with PET ProcedurePopulation: Outcome Measure Data Table reflects data from the 22 subjects completing the current study.
The percentage of patients within a given prostate specific antigen range found to have at least one abnormal lesion demonstrating increased fluorine-18 fluorocholine uptake on positron emission tomography (PET) imaging consistent with the clinical diagnosis of metastatic or recurrent prostate cancer.
Outcome measures
| Measure |
Single Arm
n=22 Participants
fluourine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
IV administration of fluorine-18 fluoromethylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.
|
|---|---|
|
Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
PSA > 0.5 - 2 ng/mL (1 cases)
|
100 %PET-positive cases in a given PSA range
|
|
Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
PSA <= 0.5 ng/mL (0 cases)
|
0 %PET-positive cases in a given PSA range
|
|
Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
PSA > 4 ng/mL (19 cases)
|
100 %PET-positive cases in a given PSA range
|
|
Prostate Specific Antigen (PSA) Outcome Correspondence to Imaging Results With Fluorine-18 Fluorocholine PET/CT
PSA 2-4 ng/mL (2 cases)
|
100 %PET-positive cases in a given PSA range
|
Adverse Events
Single Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sandi Kwee, Principal Investigator
The Queen's Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place