Patients with primary prostate cancer in which prostate cancer is histologically confirmed and a prostatectomy is planned. MedDRA version: 18.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [68Ga]RM2
Pharmaceutical Form: Injection
INN or Proposed INN: [68Ga]RM2
Current Sponsor code: [68Ga]RM2
Other descriptive name: [68GA]DOTA-4-AMINO-1-CARBOXYMETHYLPIPERIDINE-D-PHE-GLN-TRP
Sponsors
Piramal Imaging SA
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Written informed consent. 2. Males = 45 years of age. 3. Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available. 4. Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan). 5. 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. 6. 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. 7. 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. 8. Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy 9. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments). 10. Confirmation of adequate function of major organs and systems. 11. No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening. 12. No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin). 13. Life expectancy of at least 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55 ;Inclusion criteria: 1. Written informed consent. 2. Males = 45 years of age. 3. Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available. 4. Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan). 5. 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. 6. 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. 7. 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. 8. Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy 9. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments). 10. Confirmation of adequate function of major organs and systems. 11. No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening. 12. No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin). 13. Life expectancy of at least 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55 ;Inclusion criteria: 1. Written informed consent. 2. Males = 45 years of age. 3. Patients with primary prostate cancer in which prostate cancer is histologically confirmed and results of histology are available. 4. Patient with planned prostatectomy (within 4 weeks following the [68Ga]RM2 scan). 5. 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. 6. 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. 7. 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. 8. Recovery (excluding alopecia) from previous surgery, radiation, and chemotherapy 9. ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (see Attachments). 10. Confirmation of adequate function of major organs and systems. 11. No clinically relevant deviations in renal function as determined by Cockcroft and Gault method using serum creatinine at screening. 12. No malfunction equivalent to CTC (Common toxicity criteria) toxicities grade > 2 of the liver (ALT; bilirubin). 13. Life expectancy of at least 3 months. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
Exclusion criteria: 1. 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. 2. Known sensitivity to the study drug or components of the preparation. 3. Patient is in custody by order of an authority or a court of law. 4. Patient is a relative of the investigator, student of the investigator or otherwise dependent. 5. 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. 6. Unwillingness or inability to comply with the protocol. 7. 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. 8. 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. 9. History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines). 10. Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration. ;Exclusion criteria: 1. 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. 2. Known sensitivity to the study drug or components of the preparation. 3. Patient is in custody by order of an authority or a court of law. 4. Patient is a relative of the investigator, student of the investigator or otherwise dependent. 5. 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. 6. Unwillingness or inability to comply with the protocol. 7. 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. 8. 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. 9. History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines). 10. Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration. ;Exclusion criteria: 1. 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. 2. Known sensitivity to the study drug or components of the preparation. 3. Patient is in custody by order of an authority or a court of law. 4. Patient is a relative of the investigator, student of the investigator or otherwise dependent. 5. 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. 6. Unwillingness or inability to comply with the protocol. 7. 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. 8. 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. 9. History of significant occupational exposure to ionizing radiation or monitoring of occupational radiation exposure (according to recommendations from current guidelines). 10. Donation of blood within 12 weeks or plasmapheresis within 2 weeks before the radiotracer administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the ability of [68Ga]RM2 to detect and localize primary prostate cancer using whole mount sections of the prostate as standard of truth (SOT).;Secondary Objective: • Evaluation of [68Ga]RM2 accumulation and tumor detection-rate in patients with low, intermediate and high likelihood of recurrence as determined by the pre-treatment risk stratification (NCCN guidelines) • Assessment of the accumulation of [68Ga]RM2 in BPH areas of the whole mount sections • Comparison of [68Ga]RM2 findings to MRI and [18F]-choline, whenever available ([18F]-choline not mandatory) • Quantitative comparison of [68Ga]RM2 uptake in patients with low, intermediate or high likelihood of recurrence • Exploratory evaluation of a quantitative (SUV) threshold to distinguish low and intermediate and high risk patients based on post-surgery histopathology • Evaluation of safety and tolerability of [68Ga]RM2 ;Primary end point(s): Overall lesion detection rate Cancer lesion detection rate Visual assessment of images with scores;Timepoint(s) of evaluation of this end point: After the results of the 30 patients from part 1 are available, the Sponsor will analyze all available PET/CT imaging and histopathological data (i.e. histopathological results, MRI and [18F]-choline and [68Ga]RM2 PET/CT). Final analysis will take place after the results of the additional 50 patients from part 2 are available.;Main Objective: Evaluation of the ability of [68Ga]RM2 to detect and localize primary prostate cancer using whole mount sections of the prostate as standard of truth (SOT).;Secondary Objective: • Evaluation of [68Ga]RM2 accumulation and tumor detection-rate in patients with low, intermediate and high likelihood of recurrence as determined by the pre-treatment risk stratification (NCCN guidelines) • Assessment of the accumulation of [68Ga]RM2 in BPH areas of the whole mount sections • Comparison of [68Ga]RM2 findings to MRI and [18F]-choline, whenever available ([18F]-choli | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quantitative assessment: SUV, SUVR Safety;Timepoint(s) of evaluation of this end point: After the results of the 30 patients from part 1 are available, the Sponsor will analyze all available PET/CT imaging and histopathological data (i.e. histopathological results, MRI and [18F]-choline and [68Ga]RM2 PET/CT). Final analysis will take place after the results of the 50 patients from part 2 are available.;Secondary end point(s): Quantitative assessment: SUV, SUVR Safety;Timepoint(s) of evaluation of this end point: After the results of the 30 patients from part 1 are available, the Sponsor will analyze all available PET/CT imaging and histopathological data (i.e. histopathological results, MRI and [18F]-choline and [68Ga]RM2 PET/CT). Final analysis will take place after the results of the 50 patients from part 2 are available.;Secondary end point(s): Quantitative assessment: SUV, SUVR Safety;Timepoint(s) of evaluation of this end point: After the results of the 30 patients from part 1 are available, the Sponsor will analyze all available PET/CT imaging and histopathological data (i.e. histopathological results, MRI and [18F]-choline and [68Ga]RM2 PET/CT). Final analysis will take place after the results of the 50 patients from part 2 are available. | — |
Countries
Austria, Finland, United States
Contacts
Public ContactChief Medical Officer;Chief Medical Officer;Chief Medical Officer ;;
Piramal Imaging GmbH;Piramal Imaging GmbH;Piramal Imaging GmbH
Outcome results
None listed