Trial Outcomes & Findings for Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients (NCT NCT02611882)
NCT ID: NCT02611882
Last Updated: 2020-12-22
Results Overview
Patients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.
COMPLETED
PHASE2
225 participants
1 day
2020-12-22
Participant Flow
Participants were recruited through clinicians located at San Francisco Veteran's Affairs Medical Center and University of California, San Francisco Helen Diller Family Comprehensive Cancer Center
Participant milestones
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Castrate Resistant Prostate Cancer (CRCP) Population
Patients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|---|
|
Overall Study
STARTED
|
75
|
150
|
0
|
|
Overall Study
Completed Surgery Per Protocol
|
42
|
0
|
0
|
|
Overall Study
COMPLETED
|
42
|
150
|
0
|
|
Overall Study
NOT COMPLETED
|
33
|
0
|
0
|
Reasons for withdrawal
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Castrate Resistant Prostate Cancer (CRCP) Population
Patients with castrate resistant prostate cancer. Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|---|
|
Overall Study
Did not complete prostatectomy per protocol stipulation
|
33
|
0
|
0
|
Baseline Characteristics
Evaluation of Gallium-68-HBED-CC-PSMA Imaging in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
n=75 Participants
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
n=150 Participants
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Castrate Resistant Prostate Cancer (CRCP) Population
Patients with castrate resistant prostate cancer.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
40-49 years old
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Age, Customized
50-59 years old
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
—
|
29 Participants
n=4 Participants
|
|
Age, Customized
60-69 years old
|
28 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
—
|
88 Participants
n=4 Participants
|
|
Age, Customized
70-79 years old
|
29 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
—
|
93 Participants
n=4 Participants
|
|
Age, Customized
80-89 years old
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
—
|
12 Participants
n=4 Participants
|
|
Age, Customized
90-99 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
—
|
225 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
69 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
73 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
—
|
132 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
—
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
61 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
61 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
—
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
—
|
28 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
150 participants
n=7 Participants
|
—
|
225 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 dayPatients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true positive rate will be calculated with the corresponding 95% confidence interval.
Outcome measures
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
n=42 Participants
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
n=72 Participants
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|
|
Sensitivity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastases
|
.59 proportion of participants
|
.89 proportion of participants
|
PRIMARY outcome
Timeframe: 1 dayPatients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Outcome measures
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
n=42 Participants
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
n=72 Participants
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|
|
Specificity of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
|
.80 proportion of participants
|
.31 proportion of participants
|
PRIMARY outcome
Timeframe: 1 dayPatients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Outcome measures
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
n=42 Participants
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
n=72 Participants
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|
|
Positive Predictive Value (PPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
|
.67 proportion of true positives
|
.906 proportion of true positives
|
PRIMARY outcome
Timeframe: one monthPatients who have a positive node on imaging and on pathology will be considered a true-positive. Patients who have no nodes on imaging and pathology will be considered true- negatives. Patients with positive nodes on imaging and negative on pathology will be considered false positives and those with positive nodes on pathology but negative on imaging will be considered false negatives. Point estimate of the true negative rate will be calculated with the corresponding 95% confidence interval.
Outcome measures
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
n=42 Participants
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
n=77 Participants
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|
|
Negative Predictive Value (NPV) of Ga-68 HBED-CC PSMA for Detection of Nodal Metastasis
|
.74 proportion of true negatives
|
.24 proportion of true negatives
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Six patients did not have an evaluable PSA value pre-imaging for this analysis
68Ga-labeled prostate-specific membrane antigen 11 (Ga68-PSMA-11) PET positivity rate by prostate-specific antigen (PSA) level is calculated by the number of positive reads divided by the total number of patients in the BCR Group per PSA value quintile (Detection rate (d) = total number of positive reads (t)/ total number of participants (N)).
Outcome measures
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
n=144 Participants
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|
|
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
<0.5 ng/dl
|
.55 proportion of participants
|
—
|
|
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
0.5 to < 1.0 ng/dl
|
.62 proportion of participants
|
—
|
|
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
1.0 to < 2.0 ng/dl
|
.80 proportion of participants
|
—
|
|
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
2.0 to < 5.0 ng/dl
|
.88 proportion of participants
|
—
|
|
Overall Detection Rates of Ga68-PSMA-11 by PSA Levels for the BCR Group
>=5.0 ng/dl
|
.96 proportion of participants
|
—
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Surveys for only 126 BCR participants were completed by their physicians
Change in participant medical management was determined based on the results of surveys given to each participant's treating physician. Results of the survey were categorized as a major change in participant's medical management, a minor change in participant's medical management, no change to participant's medical management, or change to participant's medical management is unknown. These categories were developed based on a predetermined categorization schema.
Outcome measures
| Measure |
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
n=126 Participants
Patients with high-risk prostate cancer pre-prostatectomy.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
Biochemical Recurrence (BCR) Population
Patients with prostate cancer with biochemical recurrence.
Patients receive Ga-68-HBED-CC-PSMA and then undergo PET/CT or PET/MRI approximately 55-70 minutes later.
|
|---|---|---|
|
Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management
Major Change
|
67 Participants
|
—
|
|
Number of Patients in Biochemical Recurrence (BCR) Group Who Had a Reported Change in Medical Management
Minor Change
|
8 Participants
|
—
|
Adverse Events
High-risk Prostate Cancer Pre-prostatectomy (preRP) Population
Biochemical Recurrence (BCR) Population
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Thomas Hope, MD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place