CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
68Ga-PSMAdrug
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/NCT04614363
NCT04614363Phase 2Completed
CompareCT.gov

Comparison of 68 Ga-PSMA Positron Emission Tomography (PET)/CT to Conventional Imaging in Men With High Risk Prostate Cancer

The Methodist Hospital Research Institute·interventional·Posted Nov 4, 2020·Updated Aug 28, 2023

In Brief

A Phase 2 clinical trial evaluating 68Ga-PSMA for Prostate Cancer and High Risk. Completed, enrolled 80 participants across 1 site.

Detailed Summary

This is a prospective, single-center, open-label pilot study of 68GA-PSMA-11 given at a single time prior to PET/CT imaging in men with localized high risk prostate cancer or biochemical recurrence. The imaging agent (68 Ga-PSMA 11 will be administered on an outpatient basis. It will be administered prior to the PET/CT imaging. The objective is to evaluate the distribution of 68GA-PSMA-11 in tissues and to determine if this alters the planned clinical management.

Study Details

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

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedNov 4, 2020
Enrollment StartOct 13, 2020
Primary CompletionFeb 26, 2022
Study CompletionApr 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.7 years ago

Interventions

68Ga-PSMAdrug

All subjects enrolled in the study will receive a single IV dose of 3-7 mCi of 68 Ga-PSMA (study drug) followed by PET/CT imaging for detection of tumor location.