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

TERMINATEDPHASE1/PHASE2

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

NCT02483884•Life Molecular Imaging SA

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Written informed consent.
•Patients with diagnosis of primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available.
•Patient with planned prostatectomy (within 4 weeks following the \[68Ga\]RM2 scan).
•Patient had a MRI, and \[18F\]-choline PET/CT (when available), for primary detection or staging and the images and the results are available (Note: \[18F\]-choline PET/CT is optional) or the MRI examination is already scheduled at the time of the screening visit for a date before prostatectomy.
•The MRI and \[18F\]-choline PET/CT referred to in criterion 5 were performed preferably within not more than 5 days prior to the planned imaging with \[68Ga\]RM2. The maximum interval between MRI and \[18F\]-choline PET/CT and treatment with \[68Ga\]RM2 PET/CT is 6 weeks. However, if required, the MRI examination can also be performed after the \[68Ga\]RM2 PET/CT, but is already scheduled at the time of the screening visit for a date before prostatectomy.
•No chemotherapy, radiotherapy, biopsy or immune/biologic therapy between MRI and \[18F\]-choline PET/CT (when performed) and \[68Ga\]RM2 PET/CT performed or scheduled.
•NOTE: If MRI is performed after the \[68Ga\]RM2 PET/CT, no chemotherapy, radiotherapy, biopsy or immune/biologic therapy between \[68Ga\]RM2 PET/CT and MRI examination is allowed.
•Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy
•ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments).
•No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening.
+2 more criteria

Exclusion Criteria

•Concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of \[68Ga\]RM2, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study.
•Known sensitivity to the study drug or components of the preparation.
•Patient is in custody by order of an authority or a court of law.
•Patient is a relative of the investigator, student of the investigator or otherwise dependent.
•Patient is participating in another clinical study involving administration of an investigational drug at the same time as well as in the preceding 4 weeks before radiotracer administration. Participation in another clinical study involving administration of an investigational drug has ended within the preceding 4 weeks before radiotracer administration.
•Unwillingness or inability to comply with the protocol.
•Patient fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety.
•Hematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator, i.e. CTC (Common toxicity criteria) toxicities grade \> 2. Minor deviations in lab parameters that are considered by the evaluating physician to be not clinically significant with respect to safety or interpretation of study results are not considered an exclusion criterion.
•History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines).
•Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer Administration.

Locations (2)

Krankenhaus der Barmherzigen Schwestern

Linz, Austria

Turku PET Centre/Department of Oncology and Radiotherapy

Turku, Finland

Key Dates

Start Date

May 1, 2015

Primary Completion Date

December 1, 2016

Completion Date

December 1, 2016

Last Updated

March 22, 2017

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

[68Ga]RM2

DRUG

PET/CT

PROCEDURE

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Metastatic Prostate Adenocarcinoma With Neuroendocrine DifferentiationMetastatic Prostate Neuroendocrine Carcinoma+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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