PSMA-PET to Guide Prostatectomy

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Five Eleven Pharma, Inc.
Study ID
NCT05381103
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 1, 2021
Status verified
Oct 2024
Primary completion
Jun 1, 2028
Completion
Dec 1, 2028

Study Design

Enrollment
288 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: PSMA-PET and SOC MRI prior to surgery
  • Active Comparator: SOC MRI prior to surgery

Primary Outcome Measure

IIEF-EF sub scale score [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of MedicineIndianapolisIndiana46202
Mark Green, Ph.D

Find similar trials in Indianapolis, IN

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Goodman Hall, Indiana Institute for Biomedical Imaging Sciences, Indiana University School of Medicine· Indianapolis, IN

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