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NCT Number: NCT05381103

PSMA-PET to Guide Prostatectomy

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.

Recruiting

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Key information

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days.
  • Does not meet safety criteria for MRI scan (e.g. metal implant that is not allowed, since MRI is required for comparison).
  • 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.

Treatment and study plan

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

SOC MRI

Diagnostic Test

Standard of care MRI

Primary outcomes

  1. IIEF-EF sub scale score

    Time frame: 1 month

    International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.

  2. IIEF-EF sub scale score

    Time frame: 3 months

    International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.

  3. IIEF-EF sub scale score

    Time frame: 6 months

    International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.

  4. IIEF-EF sub scale score

    Time frame: 12 months

    International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.

  5. IIEF-EF sub scale score

    Time frame: 18 months

    International Index Erectile Function-Erectile Function sub scale score. Maximum score is 30 with higher score indicating better outcomes.

Secondary outcomes

  1. Change in treatment plan

    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

  2. Ratio of positive surgical margins to nerve bundles spared

    Time frame: 1 month

  3. EPE detection

    Time frame: 1 month

    Sensitivity/Specificity for extra-prostatic extension of cancer at the nerve bundles

  4. Incontinence bother

    Time frame: 18 months

    Expanded Prostate Cancer Index Composite (EPIC-26) questions 1-2

  5. Incontinence: using 0-1 pads per day

    Time frame: 18 months

    Expanded Prostate Cancer Index Composite (EPIC-26) question 3

  6. Urgency/frequency

    Time frame: 18 months

    Expanded Prostate Cancer Index Composite (EPIC-26) questions 4-5

  7. Erectile dysfunction: ability to achieve erection sufficient for penetration

    Time frame: 18 months

    IIEF question 3

  8. Overall mental and physical health

    Time frame: 18 months

    Short Form quality of life questionnaire (SF-36)

  9. Surgical margins

    Time frame: 1 month

    postive surgical margin rates

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Lehman

CONTACT

[email protected]

317-274-1791

Sponsors and collaborators

Lead sponsor

Five Eleven Pharma, Inc.

Industry

Collaborators

  • Indiana University

Registry information

Official study title

PSMA-PET to Guide Prostatectomy: A Randomized Trial

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 19, 2022
Registry last updated
Jan 31, 2025

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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