At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 1,435 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/NCT03396874

NCT03396874Phase 2Completed

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Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

University of Michigan·interventional·Posted Jan 11, 2018·Updated Nov 3, 2023

In Brief

A Phase 2 clinical trial evaluating 68Ga-PSMA for Prostate Cancer and 3 related conditions. Completed, enrolled 1,435 participants across 1 site.

Detailed Summary

This study evaluates the value of Gallium-68 labeled PSMA (68Ga-PSMA) for PET/CT imaging of prostate cancer recurrence. 68Ga-PSMA is a radioactive molecule, which binds to prostate cancer cells. Together with a PET/CT scanner, the distribution of 68Ga-PSMA can be determined in the body. To test this new drug, participants will receive an intravenous injection of Ga-68-PSMA and then have a PET/CT scan. The scan results will be made available to study participants and treating physicians.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsProstate Cancer, Prostate Adenocarcinoma, Prostate Cancer Metastatic, Prostate Cancer Recurrent

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

201820192020202120222023202420252026

First PostedJan 2018

Enrollment StartFeb 2018

Primary CompletionAug 2022

TodayJul 2026

First PostedJan 11, 2018

Enrollment StartFeb 9, 2018

Primary CompletionAug 9, 2022

TodayJul 2, 2026

Enrollment to primary: 4.5 yearsPosted 8.5 years ago

Interventions

68Ga-PSMAdrug

PET/CT imaging with 68Ga-PSMA: 68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi).