Recurrent Prostate Carcinoma
Conditions
Brief summary
This clinical trial studies gallium-68 (68Ga)-prostate specific membrane antigen (PSMA) (gallium Ga 68-labeled PSMA ligand Glu-urea-Lys\[Ahx\]) positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in identifying prostate cancer that may have returned after a period of improvement (biochemical recurrence). 68Ga-PSMA is a radiopharmaceutical that localizes to a specific prostate cancer receptor, which can then be imaged by the PET/CT or PET/MRI scanner.
Detailed description
PRIMARY OBJECTIVES: Evaluate the feasibility and biodistribution of 68Ga-PSMA. OUTLINE: Patients are injected with 5 mCi of Ga68 PSMA intravenously (IV) and then undergo PET/CT or PET/MRI approximately 45 to 60 minutes later. After completion of study, patients are followed up at 24 hours and 1 week.
Interventions
PROCEDUREComputed Tomography
Part of PET/CT scan
DRUGGallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)
Intravenously-administered (IV) radioisotope
PROCEDUREMagnetic Resonance Imaging
Part of PET/MRI scan
PROCEDUREPositron Emission Tomography
Part of PET/CT and/or PET/MRI scans
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provides written informed consent * Known diagnosis of prostate cancer * Patient has suspected recurrence based on biochemical data (prostate specific antigen \[PSA\] \> 2 ng/mL) * Able to remain still for duration of each imaging procedure (about one hour)
Exclusion criteria
* Unable to provide informed consent * Inability to lie still for the entire imaging time * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | an estimated average of 1 hour | The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI. |
| Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | an estimated average of 1 hour | The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI. |
| Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio) | an estimated average of 1 hour | Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background. |
| Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio) | an estimated average of 1 hour | Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan | an estimated average of 2 hours | Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (68Ga-PSMA PET/CT or PET/MRI) Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Diagnostic (68Ga-PSMA PET/CT or PET/MRI) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)
Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmax (a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.
Time frame: an estimated average of 1 hour
Population: 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio) | 10.4 F/N ratio | Standard Deviation 9.3 |
Primary
Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a standardized uptake value maximum (SUVmax), which is a semi-quantitative measurement of the maximum value of radiopharmaceutical uptake within the ROI.
Time frame: an estimated average of 1 hour
Population: 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmax. The mediastinal blood pool was used to determine average background.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | 12.4 SUVmax | Standard Deviation 7.1 |
Primary
Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)
Focal uptake will be measured by drawing regions-of-interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean (a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI). The result will be expressed as the F/N ratio, ie, SUVmax of focal uptake divided by SUVmax of background.
Time frame: an estimated average of 1 hour
Population: 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio) | 9.2 F/N ratio | Standard Deviation 7.3 |
Primary
Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution
The biodistribution (ie, the location(s) of physiologic radiopharmaceutical uptake within the body) of Ga68 PSMA will be evaluated using PET/CT or PET/MRI. Biodistribution will be measured by drawing regions of interest (ROI) around areas with visually appreciable increased focal uptake over background (mediastinal blood pool) and calculating a SUVmean which is a semi-quantitative measurement of the average value of radiopharmaceutical uptake within the ROI.
Time frame: an estimated average of 1 hour
Population: 45 areas of high Ga68 PSMA focal uptake outside the normal biodistribution were used to calculate the average SUVmean. The mediastinal blood pool was used to determine average background.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution | 7.1 SUVmean | Standard Deviation 4 |
Secondary
Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan
Feasibility of Ga68 PSMA PET/CT or PET/MRI is expressed as the number of subjects for whom the scan was successfully completed.
Time frame: an estimated average of 2 hours
Population: The population analyzed included all participants receiving Ga-68 PSMA PET/CT or PET/MRI scan.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (68Ga-PSMA PET/CT or PET/MRI) | Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan | 10 participants |