Trial Outcomes & Findings for 68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer (NCT NCT02488070)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

an estimated average of 1 hour

Results posted on

2018-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	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. Computed Tomography: Undergo PET/CT Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Given IV Laboratory Biomarker Analysis: Correlative studies Magnetic Resonance Imaging: Undergo PET/MRI Positron Emission Tomography: Undergo PET/CT Positron Emission Tomography: Undergo PET/MRI
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

68Ga-PSMA PET/CT or PET/MRI in Evaluating Patients With Recurrent Prostate Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (68Ga-PSMA PET/CT or PET/MRI) n=10 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-PSMA PET/CT or PET/MRI) n=10 Participants 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.
Average SUVmax of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution	12.4 SUVmax Standard Deviation 7.1

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-PSMA PET/CT or PET/MRI) n=10 Participants 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.
Average SUVmean of Ga68 PSMA Uptake Outside the Expected Normal Biodistribution	7.1 SUVmean Standard Deviation 4.0

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-PSMA PET/CT or PET/MRI) n=10 Participants 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.
Average SUVmax Focal Uptake of Ga68 PSMA (F/N Ratio)	10.4 F/N ratio Standard Deviation 9.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-PSMA PET/CT or PET/MRI) n=10 Participants 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.
Average SUVmean Focal Uptake of Ga68 PSMA (F/N Ratio)	9.2 F/N ratio Standard Deviation 7.3

SECONDARY outcome

Timeframe: an estimated average of 2 hours

Population: The population analyzed included all participants receiving 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.

Outcome measures

Outcome measures
Measure	Diagnostic (68Ga-PSMA PET/CT or PET/MRI) n=10 Participants 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.
Feasibility of Ga-68 PSMA PET/CT or PET/MRI Scan	10 participants

Adverse Events

Diagnostic (68Ga-PSMA PET/CT or PET/MRI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrei Iagaru, MD

Stanford University

Phone: 650-725-4711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place