NCT02483884

PET/CT Imaging Study of the Safety and Diagnostic Performance of [68Ga]RM2 in Patients With Primary Prostate Cancer

An Open-label, Multi Center PET/CT Study for Investigation of Safety and Diagnostic Performance of the 68Ga Labeled PET Tracer [68Ga]RM2 in Patients With Primary Prostate Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Life Molecular Imaging SA · Industry
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate safety and diagnostic performance of the 68Ga labeled PET tracer \[68Ga\]RM2 for detection and localization of primary prostate cancer confirmed by histopathology of the prostate as a standard of truth. This is an open-label, multi center PET/CT (positron emission tomography/computed tomography) non-randomized study. The study comprises 2 parts with an interim analysis after Part 1. In Part 1 a total of 30 subjects with biopsy-proven primary prostate cancer will be enrolled. Three strata of patients for the first part will be enrolled based on their pretreatment recurrence risk assessment according to the NCCN guidelines: 10 patients with low, 10 patients with intermediate and 10 patients with high pretreatment risk of recurrence.

Detailed description

For inclusion, the prostate cancer needs to be histologically confirmed and MRI and PET/CT with \[18F\]-choline (18F-choline is not mandatory) should be available for comparison. Diagnostic \[68Ga\]RM2 will be injected intravenously into the subjects, and PET/CT imaging performed. Images will be assessed visually and quantitatively. Subjects should be scheduled for subsequent prostatectomy within 4 weeks after PET scan. Prostate cancer will be confirmed by histopathological step-section analysis following prostatectomy and used as Standard of Truth. Based on the results of the initial 30 patients, an expansion cohort of 50 patients for Part 2 will be enrolled to increase the safety and tolerability database and to further characterize the uptake of \[68Ga\]RM2 in specific subsets.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	[68Ga]RM2	\[68Ga\]RM2 is a novel 68Ga labeled, radiopharmaceutical agent for PET imaging. It is administered intravenously as a single dose of 140 MBq (corresponding to ≤ 40 μg mass dose)
PROCEDURE	PET/CT	Patients received \[68Ga\]RM2 undergo PET/CT 60 min p.i. for at least 20 min

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-06-29
• Last updated: 2017-03-22

Locations

2 sites across 2 countries: Austria, Finland