CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Gallium Ga 68-labeled GRPR Antagonist BAY86-7548 +3 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/NCT03113617
NCT03113617Phase 2Completed
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68Ga-RM2 PET/CT for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-Risk Prostate Cancer

Andrei Iagaru·interventional·Posted Apr 13, 2017·Updated Dec 12, 2023

In Brief

A Phase 2 clinical trial evaluating Computed Tomography, Gallium Ga 68-labeled GRPR Antagonist BAY86-7548, and 2 other interventions for Stage II Prostate Adenocarcinoma and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This phase II trial studies how well gallium Ga 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/computed tomography (CT) works in detecting regional nodal and distant metastases in patients with intermediate or high-risk prostate cancer. 68Ga-RM2 PET/CT scan may be able to see smaller tumors than the standard of care CT or magnetic resonance imaging scan.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage II Prostate Adenocarcinoma, Stage III Prostate Adenocarcinoma, Stage IV Prostate Adenocarcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 13, 2017
Enrollment StartApr 10, 2017
Primary CompletionDec 19, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.2 years ago

Interventions

Computed Tomographyprocedure

Undergo PET/CT

Gallium Ga 68-labeled GRPR Antagonist BAY86-7548drug

Given IV

Laboratory Biomarker Analysisother

Correlative studies

Positron Emission Tomographyprocedure

Undergo PET/CT