Trial Outcomes & Findings for 68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment (NCT NCT02673151)
NCT ID: NCT02673151
Last Updated: 2022-01-13
Results Overview
Participants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
61 participants
Primary outcome timeframe
up to 12 months
Results posted on
2022-01-13
Participant Flow
Participant milestones
| Measure |
Diagnostic (68Ga-PSMA-11 PET/CT)
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment
Baseline characteristics by cohort
| Measure |
Diagnostic (68Ga-PSMA-11 PET/CT)
n=61 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=93 Participants
|
|
Age, Continuous
|
70.5 years
STANDARD_DEVIATION 6.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: up to 12 monthsParticipants had suspected prostate cancer recurrence, and were evaluated with 68Ga-PSMA-11 PET/CT and by conventional methodologies, eg, histopathology/biopsy and/or conventional imaging. The outcome will be reported as the percentage of participants for whom the 68Ga-PSMA-11 PET/CT scan was positive (confirmed by conventional methodologies) or negative (not confirmed by conventional methodologies). The outcome is reported as the number of participants without dispersion. Up to 1 year was allowed for result by the conventional methodology.
Outcome measures
| Measure |
Diagnostic (68Ga-PSMA-11 PET/CT)
n=61 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
|---|---|---|---|---|---|
|
Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT
Tumor-positive by 68Ga-PSMA-11 PET/CT
|
46 Participants
|
—
|
—
|
—
|
—
|
|
Confirmation of Prostate Cancer Recurrence by 68Ga-PSMA-11 PET/CT
Tumor-negative by 68Ga-PSMA-11 PET/CT
|
15 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 months68Ga-PSMA-11 PET/CT sensitivity and specificity were assessed by comparing 68Ga-PSMA-11 PET/CT scan results with conventional imaging follow-up and/or histopathology/biopsy within the following 1 year. Sensitivity is a percentage that estimates, within a group of participants, the proportion within that group that truly has a disease or condition. Specificity is a percentage that estimates, within a group of participants, the proportion within that group that truly does not have the disease or condition. The outcome is reported as the point estimates for sensitivity and specificity, given as percentages representing agreement between the 68Ga-PSMA-11 PET/CT scan result and the conventional assessment, and the 95% CI. A higher point estimate represents better agreement between the methodologies.
Outcome measures
| Measure |
Diagnostic (68Ga-PSMA-11 PET/CT)
n=61 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
|---|---|---|---|---|---|
|
68Ga-PSMA-11 PET/CT Sensitivity and Specificity
Sensitivity
|
100.0 percentage point estimate
Interval 96.3 to 100.0
|
—
|
—
|
—
|
—
|
|
68Ga-PSMA-11 PET/CT Sensitivity and Specificity
Specificity
|
86.8 percentage point estimate
Interval 81.8 to 90.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 monthsPositive predictive value (PPV) is the probability that participants with a positive screening test truly have the disease, and negative predictive value (NPV) is the probability that participants with a negative screening test truly do not have the disease. Predictive Value for 68Ga-PSMA-11 PET/CT was assessed by evaluating scans of the prostate, pelvic lymph nodes, paraaortic lymph nodes, mediastinal lymph nodes, bone, and lung. The outcome is reported as the probability as a percentage and the 95% CI.
Outcome measures
| Measure |
Diagnostic (68Ga-PSMA-11 PET/CT)
n=61 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
|---|---|---|---|---|---|
|
68Ga-PSMA-11 PET/CT Predictive Value by Region
Positive predictive value (PPV)
|
76.4 percentage point estimate
Interval 68.0 to 83.5
|
—
|
—
|
—
|
—
|
|
68Ga-PSMA-11 PET/CT Predictive Value by Region
Negative predictive value (NPV)
|
100.0 percentage point estimate
Interval 98.2 to 100.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: up to 12 monthsScan quality was assessed by sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) determinations for the 68Ga-PSMA-11 PET/CT scans in participants stratified by prostate-specific antigen (PSA) level in ng/mL. Stratification levels were as follows. * 0.2 to \< 0.5 * 0.5 to \< 1.0 * 1.0 to \< 2.0 * 2.0 to \< 5.0 * ≥ 5.0, The outcome is expressed as the Sensitivity, Specificity, PPV, and NPV values observed for the PSA level strata, with 95% confidence interval.
Outcome measures
| Measure |
Diagnostic (68Ga-PSMA-11 PET/CT)
n=16 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 0.5 to < 1.0 ng/mL
n=13 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 1.0 to < 2.0 ng/mL
n=4 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA 2.0 to < 5.0 ng/mL
n=11 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
Diagnostic (68Ga-PSMA-11 PET/CT) for PSA ≥ 5.0 ng/mL
n=17 Participants
Patients receive 68Ga-PSMA-11. Participant will be injected IV with 3 to 7 mCi of 68Ga PSMA 11 Beginning 50 to 100 minutes later, a low dose CT will be obtained from vertex to mid thighs; followed by a static PET emission scan over the same.
* 68Ga-PSMA-11: Given IV
* Computed Tomography: Undergo 68Ga-PSMA-11 PET/CT
* Positron Emission Tomography: Undergo 68Ga-PSMA-11 PET/CT
|
|---|---|---|---|---|---|
|
Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
Sensitivity
|
100.0 percentage point estimate
Interval 47.8 to 100.0
|
100.0 percentage point estimate
Interval 78.2 to 100.0
|
100.0 percentage point estimate
Interval 39.8 to 100.0
|
100.0 percentage point estimate
Interval 85.2 to 100.0
|
100.0 percentage point estimate
Interval 92.9 to 100.0
|
|
Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
Positive predictive value (PPV)
|
31.3 percentage point estimate
Interval 11.0 to 58.7
|
75 percentage point estimate
Interval 50.9 to 91.3
|
100.0 percentage point estimate
Interval 39.8 to 100.0
|
82.1 percentage point estimate
Interval 63.1 to 93.9
|
84.7 percentage point estimate
Interval 73.0 to 92.8
|
|
Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
Negative predictive value (NPV)
|
100.0 percentage point estimate
Interval 96.9 to 100.0
|
100.0 percentage point estimate
Interval 91.2 to 100.0
|
NA percentage point estimate
Insufficient number of participants with events.
|
100.0 percentage point estimate
Interval 78.2 to 100.0
|
100.0 percentage point estimate
Interval 86.8 to 100.0
|
|
Overall 68Ga-PSMA-11 PET/CT Scan Quality Stratified by PSA Level
Specificity
|
91.4 percentage point estimate
Interval 85.1 to 95.6
|
88.9 percentage point estimate
Interval 75.9 to 96.3
|
NA percentage point estimate
Insufficient number of participants with events.
|
75.0 percentage point estimate
Interval 50.9 to 91.3
|
74.3 percentage point estimate
Interval 56.7 to 87.5
|
Adverse Events
Diagnostic (68Ga-PSMA-11 PET/CT)
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, Professor of Radiology (Nuclear Medicine)
Stanford University
Phone: (650) 725-4711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place