Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Location contact
Mark Green, Ph.D
CONTACT
NCT Number: NCT05381103
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.
Interested in participating?
Request Info40 year–80 year
Male
Interventional
Phase 2 / Phase 3
Indianapolis, Indiana, 46202, United States
Location status: Recruiting
Mark Green, Ph.D
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
60 min continuous acquisition of PET data after 3-6 mCI injection of [68Ga]P16-093 followed by contrast-CT
Standard of care MRI
Time frame: 1 month
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 3 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 6 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 12 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 18 months
International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.
Time frame: 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
Time frame: 1 month
Time frame: 1 month
Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles
Time frame: 18 months
Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2
Time frame: 18 months
Expanded Prostate Cancer Index Composite (EPIC-26) question 3
Time frame: 18 months
Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5
Time frame: 18 months
IIEF question 3
Time frame: 18 months
Short Form quality of life questionnaire (SF-36)
Time frame: 1 month
postive surgical margin rates
Contact information is provided by the study sponsor or research team.
Five Eleven Pharma, Inc.
Industry
PSMA-PET to Guide Prostatectomy: A Randomized Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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