Last updated on April 2018

68Ga-RM2 PET/MRI in Biochemically Recurrent Prostate Cancer


Brief description of study

This phase II/III trial studies how well gallium (Ga) 68-labeled gastrin-releasing peptide receptor (GRPR) antagonist BAY86-7548 (68Ga-RM2) positron emission tomography (PET)/magnetic resonance imaging (MRI) works in detecting prostate cancer in patients with negative computed tomography (CT) scan and elevated prostate-specific antigen levels after treatment with surgery or radiation. PET/MRI scans take both PET and MRI images at the same time and combine them into a single picture and is used to describe information regarding the function, as well as location and size of a tumor. 68Ga-RM2, a compound made of a radioactive agent linked to a pharmacological substance that is strongly attracted by a substance made by tumor cells, to detect prostate cancer. 68Ga-RM2 PET/MRI may be able to see smaller tumors than the standard of care contrast-enhanced CT or MRI scan

Detailed Study Description

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-RM2 (formerly known as DOTA bombesin or BAY 86-7548) PET/MRI for detection of recurrent prostate cancer after initial therapy in patients with elevated prostate-specific antigen (PSA) and non-contributory computed tomography (CT).

OUTLINE

Patients receive 68Ga-RM2 intravenously (IV) and beginning 45 minutes later undergoing PET/MRI scan. The 68Ga-RM2 PET/MRI may be repeated at the completion of treatment to evaluate response to therapy, if requested by the treating physician.

After completion of study, patients are followed up at 24-48 hours and then at 1 year.

Clinical Study Identifier: NCT02624518

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Recruitment Status: Open


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