In this study, 196 patients will be randomized 1:1 to either having only the standard of care MRI prior to surgery versus having the standard of care MRI and the PSMA PET scan. PET (and MRI) findings will be validated against whole mount pathology. Pre-surgical imaging findings will also be evaluated in the context of affecting subsequent surgical plans and impacting actual patient outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
288
60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT
Standard of care MRI
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, United States
RECRUITINGIIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 1 month
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 3 months
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 6 months
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 12 months
IIEF-EF sub scale score
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 18 months
Change in treatment plan
Proportion of patients whose treatment plan would be changed by PSMA-PET. Treatment changes are defined as any change in surgical resection plan that affects one of 4 critical regions for quality of life
Time frame: 1 month
Ratio of positive surgical margins to nerve bundles spared
Time frame: 1 month
EPE detection
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Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles
Time frame: 1 month
Incontinence bother
Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2
Time frame: 18 months
Incontinence: using 0-1 pads per day
Expanded Prostate Cancer Index Composite (EPIC-26) question 3
Time frame: 18 months
Urgency/frequency
Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5
Time frame: 18 months
Erectile dysfunction: ability to achieve erection sufficient for penetration
IIEF question 3
Time frame: 18 months
Overall mental and physical health
Short Form quality of life questionnaire (SF-36)
Time frame: 18 months
Surgical margins
postive surgical margin rates
Time frame: 1 month