Trial Outcomes & Findings for The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer (NCT NCT04179968)
NCT ID: NCT04179968
Last Updated: 2023-03-20
Results Overview
Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
During PET/CT imaging, up to 2 hours
Results posted on
2023-03-20
Participant Flow
Participant milestones
| Measure |
Patients With Suspected Prostate Cancer
Patients with suspected prostate cancer who have at least one Prostate Imaging Reporting \& Data System (PI-RADS) 5 lesion, or at least one PI-RADS 4 lesion and prostate-specific antigen (PSA) ≥10 nanograms/milliliter (ng/mL), on standard of care multiparametric (mpMRI) of the prostate, who are scheduled for biopsy or radical prostatectomy
68Gallium (68Ga) prostate-specific membrane antigen-11 (PSMA-11) injection: Injection of 68Ga PSMA-11
Positron Emission Tomography (PET)/Computed Tomography (CT): PET/CT scan after 68Ga PSMA-11 injection
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of 68Gallium PSMA-11 in Enhancing Diagnosis of Primary and Metastatic Prostate Cancer
Baseline characteristics by cohort
| Measure |
Patients With Suspected Prostate Cancer
n=20 Participants
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
68Ga PSMA-11 injection: Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
|
Age, Continuous
|
64.85 years
STANDARD_DEVIATION 8.54 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: During PET/CT imaging, up to 2 hoursPopulation: All patients who received a 68Ga-PSMA-11 injection for diagnosis of primary prostate cancer with PET/CT imaging.
Number of primary prostate lesions will be detected using early dynamic 68Ga-PSMA-11 PET/CT imaging. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
Outcome measures
| Measure |
Patients With Suspected Prostate Cancer
n=19 Participants
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
68Ga PSMA-11 injection: Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection
|
|---|---|
|
Number of Primary Prostate Lesions Detected on Early Dynamic 68Ga-PSMA-11 PET/CT Imaging
|
24 lesions
|
PRIMARY outcome
Timeframe: During mpMRI, up to 2 hoursPopulation: All patients who received a 68Ga-PSMA-11 injection for diagnosis of primary prostate cancer with PET/CT imaging.
Number of primary prostate lesions will be detected by using mpMRI.
Outcome measures
| Measure |
Patients With Suspected Prostate Cancer
n=19 Participants
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
68Ga PSMA-11 injection: Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection
|
|---|---|
|
Number of Primary Prostate Lesions Detected by mpMRI
|
37 lesions
|
SECONDARY outcome
Timeframe: During PET/CT imaging, up to 2 hoursPopulation: 19 patients completed 68Ga-PSMA-11 PET/CT imaging as part of the study.
Number of sites of metastatic prostate lesions will be detected using 68Ga-PSMA-11 PET/CT. PSMA is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protein.
Outcome measures
| Measure |
Patients With Suspected Prostate Cancer
n=19 Participants
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
68Ga PSMA-11 injection: Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection
|
|---|---|
|
Number of Sites of Metastatic Prostate Lesions Detected on 68Ga-PSMA-11 PET/CT
|
7 sites
|
SECONDARY outcome
Timeframe: During CT/MRI imaging, up to 2 hoursPopulation: All patients who received a 68Ga-PSMA-11 injection for diagnosis of primary prostate cancer with PET/CT imaging
Patients with metastatic prostate lesions were imaged using current standard of care imaging (CT/MRI).
Outcome measures
| Measure |
Patients With Suspected Prostate Cancer
n=19 Participants
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
68Ga PSMA-11 injection: Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection
|
|---|---|
|
Number of Sites of Metastatic Prostate Lesions Detected by Current Standard of Care Imaging (CT/MRI)
|
5 sites
|
Adverse Events
Patients With Suspected Prostate Cancer
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients With Suspected Prostate Cancer
n=20 participants at risk
Patients with suspected prostate cancer who have at least one PI-RADS 5 lesion, or at least one PI-RADS 4 lesion and PSA ≥10 nanograms/milliliter (ng/mL), on standard of care mpMRI of the prostate, who are scheduled for biopsy or radical prostatectomy
68Ga PSMA-11 injection: Injection of 68Ga PSMA-11
Positron Emission Tomography/Computed Tomography: PET/CT scan after 68Ga PSMA-11 injection
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
2/20 • Number of events 2 • Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events.
|
|
Gastrointestinal disorders
Nausea without emesis
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events.
|
|
General disorders
Fatigue
|
10.0%
2/20 • Number of events 2 • Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events.
|
|
Skin and subcutaneous tissue disorders
Maculopapular rash
|
5.0%
1/20 • Number of events 1 • Subjects were monitored for adverse events after injection of the investigational agent and were contacted 24 hours after completion of PET/CT imaging to assess any potentially related adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place