Trial Outcomes & Findings for 68Ga-PSMA-11 PET in Patients With Prostate Cancer (NCT NCT05197257)
NCT ID: NCT05197257
Last Updated: 2023-11-13
Results Overview
Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.
COMPLETED
PHASE3
39 participants
Immediately after administration and for 1 hour and 30 minutes afterwards
2023-11-13
Participant Flow
Participant milestones
| Measure |
Men With Pathologically Proven Prostate Adenocarcinoma
The intervention is a PET scan with the radiolabelled PSMA ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
Ga-PSMA-11: The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.
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|---|---|
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Overall Study
STARTED
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39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Baseline characteristics by cohort
| Measure |
Men With Pathologically Proven Prostate Adenocarcinoma
n=39 Participants
The intervention is a PET scan with the radiolabelled PSMA ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT scanner or a modern digital PET / MRI scanner.
Ga-PSMA-11: The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
26 Participants
n=99 Participants
|
|
Age, Continuous
|
68.7 years
STANDARD_DEVIATION 12.98 • n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Immediately after administration and for 1 hour and 30 minutes afterwardsPopulation: All patients observed for safety.
Adverse Events (AEs) will be collected and reviewed to monitor for safety. Incidence and severity of AEs and adverse events will be estimated with 95% confidence intervals summarized with descriptive statistics. CTCAE version 5.0 will be used to grade AEs.
Outcome measures
| Measure |
Adverse Events- All Grades
n=39 Participants
Number of Adverse Events (all grades) observed immediately after administration and for 1 hour and 30 minutes afterward.
|
Initial Treatment Strategy Group- Patient Management
Count of participants with newly diagnosed with prostate cancer whose providers changed the clinical management plan after review of the PSMA PET/CT results.
|
Subsequent Treatment Strategy Group
Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) or other local therapies.
Count of participants whose PSMA PET showed more prostate cancer lesions compared to conventional imaging.
|
Subsequent Treatment Strategy Group- Patient Management
Count of participants whose PSMA PET/CT scans significantly changed patient management plan
|
All Participants- Initial and Subsequent Strategy
Count of all study participants whose PSMA PET/CT scans did not show additional lesions compared to conventional imaging.
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|---|---|---|---|---|---|
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Number of Participants With Adverse Events
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0 Participants
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—
|
—
|
—
|
—
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SECONDARY outcome
Timeframe: 2 hoursDetermine the frequency of positive PSMA PET scans in relation to the PSA value before the PSMA scans and compared to conventional imaging. Results will be summarized descriptively with 95% confidence intervals. Determine rate of overall changes in management by comparing planned management strategy using conventional imaging with executed management strategy incorporating information from 68Ga-PSMA-11 PET/CT, regardless of treatment modality. Analysis: The rate of change in management based on the incorporation of68Ga-PSMA-11 PET/CT results will be expressed as the percentage of total patients imaged in which change in management occurred, regardless of treatment modality. The rate of change in management will also be estimated within each group (initial staging, biochemical recurrence, and pre/post treatment). 95% confidence intervals (CIs) will be used to express precision of the estimates.
Outcome measures
| Measure |
Adverse Events- All Grades
n=12 Participants
Number of Adverse Events (all grades) observed immediately after administration and for 1 hour and 30 minutes afterward.
|
Initial Treatment Strategy Group- Patient Management
n=12 Participants
Count of participants with newly diagnosed with prostate cancer whose providers changed the clinical management plan after review of the PSMA PET/CT results.
|
Subsequent Treatment Strategy Group
n=27 Participants
Biochemical Recurrence: Rising PSA after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) or other local therapies.
Count of participants whose PSMA PET showed more prostate cancer lesions compared to conventional imaging.
|
Subsequent Treatment Strategy Group- Patient Management
n=27 Participants
Count of participants whose PSMA PET/CT scans significantly changed patient management plan
|
All Participants- Initial and Subsequent Strategy
n=39 Participants
Count of all study participants whose PSMA PET/CT scans did not show additional lesions compared to conventional imaging.
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|---|---|---|---|---|---|
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Compare the Diagnostic Impact of 68Ga-PSMA-11 PET/CT Imaging Over Current Standard of Care Imaging Modalities.
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12 Participants
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1 Participants
|
22 Participants
|
21 Participants
|
7 Participants
|
Adverse Events
Men With Pathologically Proven Prostate Adenocarcinoma
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