Trial Outcomes & Findings for 68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer (NCT NCT03113617)
NCT ID: NCT03113617
Last Updated: 2023-12-12
Results Overview
True positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy
COMPLETED
PHASE2
44 participants
week 1 study visit following radiopharmaceutical administration, up to 2 hours to assess
2023-12-12
Participant Flow
Participant milestones
| Measure |
Diagnostic (68Ga-RM2 PET/CT)
Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.
Computed Tomography: Undergo PET/CT
Gallium Ga 68-labeled GRPR Antagonist BAY86-7548: Given IV
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo PET/CT
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
68Ga-RM2 PET/CT in Detecting Regional Nodal and Distant Metastases in Patients With Intermediate or High-Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Diagnostic (68Ga-RM2 PET/CT)
n=44 Participants
Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.
Computed Tomography: Undergo PET/CT
Gallium Ga 68-labeled GRPR Antagonist BAY86-7548: Given IV
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo PET/CT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=99 Participants
|
|
Age, Continuous
|
63 participant
STANDARD_DEVIATION 6.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
44 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: week 1 study visit following radiopharmaceutical administration, up to 2 hours to assessTrue positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy
Outcome measures
| Measure |
Diagnostic (68Ga-RM2 PET/CT)
n=44 Participants
Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.
Computed Tomography: Undergo PET/CT
Gallium Ga 68-labeled GRPR Antagonist BAY86-7548: Given IV
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo PET/CT
|
|---|---|
|
Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Specificity
|
55.6 percentage of cases
Interval 21.2 to 86.3
|
|
Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Sensitivity
|
92.3 percentage of cases
Interval 74.9 to 99.1
|
|
Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Positive predictive value
|
71.4 percentage of cases
Interval 29.0 to 96.3
|
|
Sensitivity, Specificity, Positive, and Negative Predictive Value of 68Ga-RM2 PET for the Detection of Regional Nodal Metastases Compared to Pathology at Radical Prostatectomy
Negative predictive value
|
85.7 percentage of cases
Interval 67.3 to 96.0
|
SECONDARY outcome
Timeframe: week 1 study visit following radiopharmaceutical administration, up to 2 hours to assessTrue positive patient is defined as PET positive for regional nodes, pathology at prostatectomy positive for regional nodes or PET positive for regional nodes, pathology negative for regional nodes, imaging after prostatectomy demonstrates node was not removed at surgery, and follow-up biopsy or imaging demonstrates presence of nodal disease. True negative patient is defined as PET negative for regional nodes, pathology at prostatectomy negative for regional nodes. False positive patient is defined as PET positive for regional nodes, pathology at prostatectomy is negative, and imaging after prostatectomy
Outcome measures
| Measure |
Diagnostic (68Ga-RM2 PET/CT)
n=44 Participants
Patients receive 68Ga-RM2 IV. Within 45-60 minutes, patients undergo a PET/CT scan. Patients may undergo a second PET/CT scan immediately after the first scan for attenuation correction. Patients may undergo also a repeat 68Ga-RM2 PET/CT scan after the completion of their treatment to evaluate response to therapy, if requested by the treating physician.
Computed Tomography: Undergo PET/CT
Gallium Ga 68-labeled GRPR Antagonist BAY86-7548: Given IV
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo PET/CT
|
|---|---|
|
Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET
Sensitivity
|
22.2 percentage of cases
Interval 2.8 to 60.0
|
|
Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET
Specificity
|
96.2 percentage of cases
Interval 80.0 to 99.9
|
|
Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET
Positive predictive value
|
66.7 percentage of cases
Interval 9.4 to 99.2
|
|
Sensitivity, Specificity, Negative and Positive Predictive Value for Detection of Regional Nodal Metastases in Comparison to Cross Sectional Imaging Performed Contemporaneously With the 68Ga-RM2 PET
Negative predictive value
|
78.1 percentage of cases
Interval 60.0 to 90.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 3 yearsCorrelation between SUVmax from gallium Ga 68-labeled GRPR antagonist BAY86-7548 PET and short axis diameter of nodal disease on cross sectional imaging correlate to presence of true pathology will be performed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: At 1 yearPatients with and without pelvic nodal metastases will be compared.
Outcome measures
Outcome data not reported
Adverse Events
Diagnostic (68Ga-RM2 PET/CT)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David G Marcellus
Stanford Medicine at Stanford University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place