PSMA-PET to Guide Prostatectomy: A Randomized Trial
Summary
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.
Arms & interventions
- Diagnostic TestPSMA-PET and SOC MRI
60 min continuous acquisition of PET data after 3-6 mCI injection of \[68Ga\]P16-093 followed by contrast-CT
- Diagnostic TestSOC MRI
Standard of care MRI
Outcome measures
Primary
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: 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
Secondary
Change in treatment plan
Time frame: 1 month
Ratio of positive surgical margins to nerve bundles spared
Time frame: 1 month
EPE detection
Time frame: 1 month
Incontinence bother
Time frame: 18 months
Incontinence: using 0-1 pads per day
Time frame: 18 months
Urgency/frequency
Time frame: 18 months
Erectile dysfunction: ability to achieve erection sufficient for penetration
Time frame: 18 months
Overall mental and physical health
Time frame: 18 months
Surgical margins
Time frame: 1 month
Eligibility criteria
Study locations (1)
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, 46202