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NCT05381103RecruitingPhase 2/3

PSMA-PET to Guide Prostatectomy

PSMA-PET to Guide Prostatectomy: A Randomized Trial

Source: ClinicalTrials.gov · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
288 (estimated)
First submitted
29 Apr 2022
Start date
1 Oct 2021
Primary completion date
1 Jun 2028
Lead sponsor
Five Eleven Pharma, Inc.
NCT number
NCT05381103

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 288
  • From 1 Oct 2021 to the primary completion date, 1 Jun 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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).

Other illness

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 40 years to 80 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.