Prostate Cancer Clinical Trial
Official title:
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
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.
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.
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