Trial Outcomes & Findings for Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer (NCT NCT03822845)
NCT ID: NCT03822845
Last Updated: 2025-04-17
Results Overview
Sensitivity was defined as the proportion of subjects correctly identified as positive by Ga-68 PSMA-11 PET/CT scans compared to a reference standard. Reference standards included conventional imaging (CT, MRI), clinical follow-up within 12 months after PET, and histopathology/biopsy when available. A true positive was defined as a lesion detected by Ga-68 PSMA PET/CT and confirmed by at least one reference standard.
COMPLETED
PHASE2/PHASE3
6 participants
Up to 12 months after the 68Ga PSMA PET scan
2025-04-17
Participant Flow
Participant milestones
| Measure |
68Ga PSMA PET Scan
Ga-68 PSMA-HBED-CC PET/CT scan
Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
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|---|---|
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Overall Study
STARTED
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6
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Clinical Accuracy of Gallium-68 PSMA PET/CT Imaging in Patients With Biochemical Recurrence of Prostate Cancer
Baseline characteristics by cohort
| Measure |
68Ga PSMA PET Scan
n=6 Participants
Ga-68 PSMA-HBED-CC PET/CT scan
Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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3 Participants
n=99 Participants
|
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Age, Continuous
|
65.5 years
n=99 Participants
|
|
Sex: Female, Male
Female
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0 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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6 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=99 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
|
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Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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6 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Up to 12 months after the 68Ga PSMA PET scanPopulation: 2 of the 6 subjects had a positive PET/CT scan. 1 of the 2 positive PET/CT scan had enough information to evaluate the results.
Sensitivity was defined as the proportion of subjects correctly identified as positive by Ga-68 PSMA-11 PET/CT scans compared to a reference standard. Reference standards included conventional imaging (CT, MRI), clinical follow-up within 12 months after PET, and histopathology/biopsy when available. A true positive was defined as a lesion detected by Ga-68 PSMA PET/CT and confirmed by at least one reference standard.
Outcome measures
| Measure |
68Ga PSMA PET Scan
n=1 Participants
Ga-68 PSMA-HBED-CC PET/CT scan
Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
|
|---|---|
|
Sensitivity of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection on a Per Patient Basis
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1.0 proportion of participants
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SECONDARY outcome
Timeframe: Up to 12 months after 68Ga PSMA PET scanPopulation: 2 of the 6 subjects had a positive PET/CT scan. 1 of the 2 positive PET/CT scan had enough information to evaluate the results.
Positive predictive value will be determined on a per-subject basis of 68Ga PSMA PET scan for detection of tumor sites, confirming against imaging, clinical follow-up, and histopathology when available.
Outcome measures
| Measure |
68Ga PSMA PET Scan
n=1 Participants
Ga-68 PSMA-HBED-CC PET/CT scan
Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
|
|---|---|
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Positive Predictive Value (PPV) of Ga 68-labeled PSMA-11 Positron Emission Tomography/Computed Tomography (PET/CT) for the Detection of Tumor Location on a Per Patient Basis
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1.0 proportion of true positives
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SECONDARY outcome
Timeframe: Up to 12 months after 68Ga PSMA PET scanPopulation: 2 of the 6 subjects had a positive PET/CT scan. Of the 2 positive PET/CT scan 0 had histopathology to evaluate the results. No analysis could be done because there was no histopathology data to use as a reference.
Sensitivity is defined as the proportion of subjects with a positive Ga-68 PSMA-11 PET/CT scan for detection of tumor location, confirmed by histopathology, on a per-subject basis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 months after 68Ga PSMA PET scanPopulation: 2 of the 6 subjects had a positive PET/CT scan.
Detection rates will be evaluated on a per-subject basis, stratified by PSA values: 0.2 - \<0.5, 0.5 - \<1.0, 1.0 \<2.0, 2.0 - \<5.0, 5.0 or greater
Outcome measures
| Measure |
68Ga PSMA PET Scan
n=2 Participants
Ga-68 PSMA-HBED-CC PET/CT scan
Ga-68 PSMA-HBED-CC PET: Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
|
|---|---|
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Determine Detection Rates on a Per-subject Basis of 68Ga PSMA-HBED-CC PET/CT When Stratified by PSA Value
0.2 - <0.5
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2 Participants
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Determine Detection Rates on a Per-subject Basis of 68Ga PSMA-HBED-CC PET/CT When Stratified by PSA Value
0.5 - < 1.0
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0 Participants
|
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Determine Detection Rates on a Per-subject Basis of 68Ga PSMA-HBED-CC PET/CT When Stratified by PSA Value
1.0 - <2.0
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0 Participants
|
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Determine Detection Rates on a Per-subject Basis of 68Ga PSMA-HBED-CC PET/CT When Stratified by PSA Value
2.0 - <5.0
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0 Participants
|
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Determine Detection Rates on a Per-subject Basis of 68Ga PSMA-HBED-CC PET/CT When Stratified by PSA Value
5.0 or greater
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0 Participants
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Adverse Events
68Ga PSMA PET Scan
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