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

NCT02483884 | Terminated Phase 1

• 2 other identifiers: RM2-01-01-142014-003027-21
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Prostate Cancer

Keywords

Bombesin; Gastrin-Releasing Peptide; Prostatic Neoplasms; Genital Diseases, Male; Genital Neoplasms, Male; Neoplasms; Neoplasms by Site; Urogenital Neoplasms; Gastrointestinal Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Pharmacologic Actions; Physiological Effects of Drugs; Therapeutic Uses

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of [68Ga]RM2 PET to identify lesions in comparison to whole-mount histopathology (number of histologically verified cancer lesions identified)

  60-80 min post injection

Secondary Outcomes (5)

• Accumulation and tumor detection-rate

  60-80 min post injection

• Accumulation of [68Ga]RM2 in BPH

  60-80 min post injection

• Proportion of lesions detected by [68Ga]RM2 PET in comparison to MRI and [18F]-choline (whenever available)

  60-80 min post injection

• Quantitative determination (Standardized Uptake Value [SUV]) of [68Ga]RM2 uptake in cancer lesions, stratified according to risk groups

  60-80 min post injection

• Evaluation of SUV threshold

  60-80 min post injection

Other Outcomes (1)

• Number of patients with adverse events

  after signing ICF until 5 days post injection

Study Arms (3)

Low risk for recurrence

EXPERIMENTAL

Diagnostic \[68Ga\]RM2 is administered to 10 primary prostate cancer patients with low risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min.

Drug: [68Ga]RM2; Procedure: PET/CT

Intermediate risk for recurrence

EXPERIMENTAL

Diagnostic \[68Ga\]RM2 is administered to 10 primary prostate cancer patients with intermediate risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min.

Drug: [68Ga]RM2; Procedure: PET/CT

High risk for recurrence

EXPERIMENTAL

Diagnostic \[68Ga\]RM2 is administered to 10 primary prostate cancer patients with high risk of recurrence who undergo PET/CT 60 min post i.v. for at least 20 min.

Drug: [68Ga]RM2; Procedure: PET/CT

Interventions

[68Ga]RM2 DRUG

\[68Ga\]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)

Also known as: [68Ga] labeled Bombesin derivative, Gallium Ga68-labeled GRPR antagonist RM2

High risk for recurrence; Intermediate risk for recurrence; Low risk for recurrence

PET/CT PROCEDURE

Patients received \[68Ga\]RM2 undergo PET/CT 60 min p.i. for at least 20 min

High risk for recurrence; Intermediate risk for recurrence; Low risk for recurrence

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade \> 2 of the liver (ALT; bilirubin).
• Life expectancy of at least 3 months.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Life Molecular Imaging SA: lead

Study Sites (2)

Krankenhaus der Barmherzigen Schwestern

Linz, 4010, Austria

Location

Turku PET Centre/Department of Oncology and Radiotherapy

Turku, 20521, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Genital Diseases, Male; Genital Neoplasms, Male; Neoplasms; Neoplasms by Site; Urogenital Neoplasms

Interventions

BAY 86-7548

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Study Officials

• Andrew Stephens, MD, PhD

  Piramal Imaging GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 29, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

AU (1); FI (1)