Trial Outcomes & Findings for Comparison Study of PET/CT or PET/MRI Imaging to Magnetic Resonance Imaging (MRI) Alone in Men With Prostate Cancer (NCT NCT03439033)
NCT ID: NCT03439033
Last Updated: 2023-03-13
Results Overview
A scan was considered positive if the clinical interpretation was suspicious based on the clinical judgement of the reader.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
273 participants
Primary outcome timeframe
At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or less
Results posted on
2023-03-13
Participant Flow
Participant milestones
| Measure |
PSMA PET/MRI Scan vs. MRI Scan
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. All subjects underwent PSMA PET and MRI from skull base to upper thighs as per convention. Participants received a single IV dose of 4 mCi (148 MBq) +/- 10% of 68Ga-PSMA-HBED-CC (study drug) followed by a PET/MRI scan, 90 min after injection.
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|---|---|
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Overall Study
STARTED
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273
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Overall Study
Participants With Biochemical Reoccurrence at Baseline
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114
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Overall Study
PSMA PET/MRI
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108
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Overall Study
PSMA PET/CT
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1
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Overall Study
PSMA Multiple PET/MRI
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0
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Overall Study
COMPLETED
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109
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Overall Study
NOT COMPLETED
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164
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Biochemical Recurrence
n=114 Participants
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. All subjects underwent PSMA PET and MRI from skull base to upper thighs as per convention. Participants received a single IV dose of 4 mCi (148 MBq) +/- 10% of 68Ga-PSMA-HBED-CC (study drug) followed by a PET/MRI scan, 90 min after injection.
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|---|---|
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Age, Continuous
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69 years
n=114 Participants
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Sex: Female, Male
Female
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0 Participants
n=114 Participants
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Sex: Female, Male
Male
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114 Participants
n=114 Participants
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Region of Enrollment
United States
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114 participants
n=114 Participants
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Stratification Based on PSA Levels
0 - <0.2 ng/ml
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23 Participants
n=114 Participants
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Stratification Based on PSA Levels
0.2 <0.5 ng/ml
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33 Participants
n=114 Participants
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Stratification Based on PSA Levels
0.5 - 2.0 ng/ml
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28 Participants
n=114 Participants
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Stratification Based on PSA Levels
>2.0 ng/ml
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28 Participants
n=114 Participants
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Stratification Based on PSA Levels
PSA Levels Unavailable
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2 Participants
n=114 Participants
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PRIMARY outcome
Timeframe: At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or lessA scan was considered positive if the clinical interpretation was suspicious based on the clinical judgement of the reader.
Outcome measures
| Measure |
PSMA PET/MRI and PET/CT Scan
n=109 Participants
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. Patients underwent either PET/MRI or PET/CT. All subjects underwent PSMA PET from skull base to upper thighs as per convention. Participants received a single IV dose of 4 mCi (148 MBq) +/- 10% of 68Ga-PSMA-HBED-CC (study drug) followed by a PET/MRI scan, 90 min after injection.
|
MRI Scan
n=109 Participants
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. All subjects underwent MRI from skull base to upper thighs as per convention.
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|---|---|---|
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Number of Subjects With Pathologic Lesions Detected by PSMA PET and PET/CT Compared to MP MRI
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63 Participants
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37 Participants
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PRIMARY outcome
Timeframe: At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or lessPopulation: Overall number of participants analyzed includes all participants who underwent MRI regardless of whether a pathologic lesion was identified.
Patients were divided into subgroups based on their PSA levels and primary treatment modality. The primary treatment modality subgroups were post radical prostatectomy, post radiation therapy, and post radical prostatectomy and radiation therapy. 109 subjects out of 273 enrolled have data reported. Multiple patients sought care elsewhere and a small number of subjects had 2-year follow-up. This lead to a smaller analysis.
Outcome measures
| Measure |
PSMA PET/MRI and PET/CT Scan
n=109 Participants
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. Patients underwent either PET/MRI or PET/CT. All subjects underwent PSMA PET from skull base to upper thighs as per convention. Participants received a single IV dose of 4 mCi (148 MBq) +/- 10% of 68Ga-PSMA-HBED-CC (study drug) followed by a PET/MRI scan, 90 min after injection.
|
MRI Scan
n=109 Participants
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. All subjects underwent MRI from skull base to upper thighs as per convention.
|
|---|---|---|
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region Stratified by PSA Level
PSA Levels 0.2 to < 0.5 ng/mL
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22 lesions
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19 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region Stratified by PSA Level
Total Number of Lesions
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92 lesions
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47 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region Stratified by PSA Level
PSA Levels 0 to < 0.2 ng/mL
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10 lesions
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0 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region Stratified by PSA Level
PSA Levels 0.5 to 2.0 ng/mL
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25 lesions
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10 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region Stratified by PSA Level
PET/MRI: PSA Levels > 2.0 ng/mL
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35 lesions
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18 lesions
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SECONDARY outcome
Timeframe: At each visit, immediately after administration of the study drug, approximately 2-3 hours; with up to two visits within 2 years or lessPopulation: Overall number of participants analyzed includes all participants who underwent MRI regardless of whether a pathologic lesion was identified.
True positive rates for detecting lesions between PSMA PET/MRI and MP MRI in various anatomical locations were compared, including prostate/prostatic bed, N1 lymph nodes, N2 lymph nodes, and osseous lesions. Other anatomical sites are other than bone, node, and prostate.
Outcome measures
| Measure |
PSMA PET/MRI and PET/CT Scan
n=109 Participants
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. Patients underwent either PET/MRI or PET/CT. All subjects underwent PSMA PET from skull base to upper thighs as per convention. Participants received a single IV dose of 4 mCi (148 MBq) +/- 10% of 68Ga-PSMA-HBED-CC (study drug) followed by a PET/MRI scan, 90 min after injection.
|
MRI Scan
n=109 Participants
These are males who were referred because of a rising PSA after definitive treatment for prostate cancer. All subjects underwent MRI from skull base to upper thighs as per convention.
|
|---|---|---|
|
Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region
Total Number of Lesions
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92 lesions
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47 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region
N1 lymph nodes
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34 lesions
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11 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region
N2 lymph nodes
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20 lesions
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7 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region
Osseous
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24 lesions
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14 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region
Prostate
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3 lesions
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7 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region
Prostatic Bed
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8 lesions
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7 lesions
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Number of Pathological Lesions Detected by PSMA PET/MRI and PET/CT Compared to MP MRI in Prostate Cancer Patients With Biochemical Recurrence by Anatomical Region
Other Anatomical Sites
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3 lesions
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1 lesions
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Adverse Events
PSMA PET/MRI Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MRI Scan
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PSMA PET/CT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PSMA Multiple 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place