Prostate Cancer
Conditions
Brief 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.
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
Sponsors
Indiana University
Five Eleven Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Significant prostate cancer: Gleason 3+4 ≥1 core with pattern 4 ≥20% Gleason 3+4 ≥1 core with ≥50% total involvement of core OR ≥3 cores of Gleason 3+4 OR NCCN unfavorable intermediate risk OR Any Gleason 4+3, 4+4, 4+5, 5+4, or 5+5 AND 2. Baseline sexual function (IIEF-EF \> 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND 3. The patient desires to maintain erections following treatment 4. Planned to undergo a standard of care MRI or recently completed standard of care MRI within 6 months of scheduled date of surgery. Note: For subjects whose SOC MRI is not within 6 months or not 3Tesla, they may be enrolled in the study and the MRI will be repeated as a research study. The research MRI will not be billed to the subject's insurance, but will be scheduled at IU ORI, at no cost to study participant. 5. Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
Exclusion criteria
1. Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days. 2. Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison). 3. Significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IIEF-EF sub scale score | 1 month | International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of positive surgical margins to nerve bundles spared | 1 month | — |
| EPE detection | 1 month | Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles |
| Incontinence bother | 18 months | Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2 |
| Incontinence: using 0-1 pads per day | 18 months | Expanded Prostate Cancer Index Composite (EPIC-26) question 3 |
| Change in treatment plan | 1 month | 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 |
| Erectile dysfunction: ability to achieve erection sufficient for penetration | 18 months | IIEF question 3 |
| Overall mental and physical health | 18 months | Short Form quality of life questionnaire (SF-36) |
| Surgical margins | 1 month | postive surgical margin rates |
| Urgency/frequency | 18 months | Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5 |
Countries
United States
Contacts
Primary ContactJennifer Lehman
Outcome results
None listed