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| Name | Class |
|---|---|
| Indiana University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSMA-PET and SOC MRI prior to surgery | Experimental |
| |
| SOC MRI prior to surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSMA-PET and SOC MRI | Diagnostic Test | 60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| IIEF-EF sub scale score | International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes. | 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. | 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. | 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. | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 month |
| Ratio of positive surgical margins to nerve bundles spared |
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Inclusion Criteria:
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
Baseline sexual function (IIEF-EF > 17): No erectile dysfunction OR mild-to- moderate erectile dysfunction (International Index of Erectile Function Domain ≥ 17) AND
The patient desires to maintain erections following treatment
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.
Planned Prostatectomy candidate per treating oncologist with prostatectomy planned within 90 days of consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Lehman | Contact | 317-274-1791 | jgeck@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Clinton Bahler, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| SOC MRI | Diagnostic Test | Standard of care MRI |
|
| 1 month |
| EPE detection | Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles | 1 month |
| Incontinence bother | Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2 | 18 months |
| Incontinence: using 0-1 pads per day | Expanded Prostate Cancer Index Composite (EPIC-26) question 3 | 18 months |
| Urgency/frequency | Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5 | 18 months |
| Erectile dysfunction: ability to achieve erection sufficient for penetration | IIEF question 3 | 18 months |
| Overall mental and physical health | Short Form quality of life questionnaire (SF-36) | 18 months |
| Surgical margins | postive surgical margin rates | 1 month |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |