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RecruitingInterventionalPhase 2/Phase 3

PSMA-PET to Guide Prostatectomy: A Randomized Trial

NCT ID: NCT05381103Sponsor: Five Eleven Pharma, Inc.Last updated: 2025-01-31

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

Sex: MaleAge: 40 Years to 80 YearsHealthy 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.

Study locations (1)

Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine

Indianapolis, Indiana, 46202

Recruiting
Mark Green, Ph.D · Contact