Business decision

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.

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

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.