At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 74 enrolled

Drug / intervention

68Ga-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/NCT02678351

NCT02678351Phase 3Completed

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68Ga-PSMA-11 PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

Andrei Iagaru·interventional·Posted Feb 9, 2016·Updated Mar 4, 2022

In Brief

A Phase 3 clinical trial evaluating 68Ga-PSMA-11, Magnetic resonance imaging (MRI), and 1 other intervention for Stage II Prostate Adenocarcinoma and Stage III Prostate Adenocarcinoma. Completed, enrolled 74 participants across 1 site.

Detailed Summary

This phase 2-3 trial studies the utility of 68-gallium (68Ga)-prostate-specific membrane antigen 11 (PSMA-11) positron emission tomography/magnetic resonance imaging (PET/MRI) to find tumors in patients with prostate cancer who are undergoing resection surgery for prostate cancer that is prognostically expected to spread quickly (intermediate-risk) or is likely to come back or spread (high-risk). Diagnostic procedures, such as PET/MRI, may help find and diagnose prostate cancer, and reveal out how far the disease has spread. Radioactive drugs, such as 68Ga-PSMA-11, may bind to tumor cells that have specific receptors, and may allow doctors to see smaller tumors than the standard of care contrast-enhanced computed tomography (CT) or MRI scan.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsStage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma

CountriesUnited States

CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished

20162017201820192020202120222023202420252026

First PostedFeb 2016

Enrollment StartApr 2016

Primary CompletionDec 2020

Study CompletionDec 2021

TodayJul 2026

First PostedFeb 9, 2016

Enrollment StartApr 18, 2016

Primary CompletionDec 13, 2020

Study CompletionDec 1, 2021

TodayJul 2, 2026

Enrollment to primary: 4.7 yearsPosted 10.4 years ago

Interventions

68Ga-PSMA-11drug

Undergo 68Ga-PSMA-11 PET/MRI

Magnetic resonance imaging (MRI)procedure

Undergo 68Ga-PSMA-11 PET/MRI

Positron Emission Tomography (PET)procedure

Undergo 68Ga-PSMA-11 PET/MRI