PSMA-PET to Guide Prostatectomy

Clinicaltrials.gov ID: NCT05381103
db-list-check Status RECRUITING
b-loader Phase PHASE2, PHASE3
b-people Age 40 - 80 Years
b-bullseye-arrow Enrollments 288

Conditions

Prostate Cancer

Summary

In this study, 288 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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Mark Green, Ph.D

Principal Investigator

  • Clinton Bahler, MD

Eligibility Criteria

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.

Outcome Measures

Primary Outcome Measures

IIEF-EF sub scale score

Time Frame: 1 month

IIEF-EF sub scale score

Time Frame: 3 months

IIEF-EF sub scale score

Time Frame: 6 months

IIEF-EF sub scale score

Time Frame: 12 months

IIEF-EF sub scale score

Time Frame: 18 months

Secondary Outcome Measures

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

Timeline

  • Last Updated
    October 30, 2024
  • Start Date
    May 19, 2022
  • Today
    January 16, 2025
  • Completion Date ( Estimated )
    March 31, 2028

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