Trials / Recruiting
RecruitingNCT05381103
PSMA-PET to Guide Prostatectomy
PSMA-PET to Guide Prostatectomy: A Randomized Trial
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 288 (estimated)
- Sponsor
- Five Eleven Pharma, Inc. · Industry
- Sex
- Male
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | PSMA-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_TEST | SOC MRI | Standard of care MRI |
Timeline
- Start date
- 2021-10-01
- Primary completion
- 2028-06-01
- Completion
- 2028-12-01
- First posted
- 2022-05-19
- Last updated
- 2025-01-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05381103. Inclusion in this directory is not an endorsement.