CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 485 enrolled
Drug / intervention
Ga-68 labeled PSMA-11 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03803475
NCT03803475Phase 3Completed
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Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

Thomas Hope·interventional·Posted Jan 14, 2019·Updated Aug 24, 2021

In Brief

A Phase 3 clinical trial evaluating Ga-68 labeled PSMA-11, Positron emission tomography-computed tomography (PET/CT), and 1 other intervention for Prostate Cancer. Completed, enrolled 485 participants across 1 site.

Detailed Summary

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 14, 2019
Enrollment StartOct 11, 2018
Primary CompletionAug 25, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.5 years ago

Interventions

Ga-68 labeled PSMA-11drug

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.

Positron emission tomography-computed tomography (PET/CT)device

Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session

Positron emission tomography-magnetic resonance imaging (PET/MRI)device

A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session