E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with primary prostate cancer in which prostate cancer is histologically confirmed and a prostatectomy is planned. |
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E.1.1.1 | Medical condition in easily understood language |
Patients with primary prostate cancer in which prostate cancer is histologically confirmed (biopsy) and surgical removal of the prostate is planned. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060862 |
E.1.2 | Term | Prostate cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall lesion detection rate
Cancer lesion detection rate
Visual assessment of images with scores |
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E.5.1.1 | 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. |
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E.5.2 | Secondary end point(s) |
Quantitative assessment: SUV, SUVR
Safety |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
study for investigation of safety and diagnostic performance |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study is defined as database closure.
In case of ongoing AEs after the last follow-up telephone contact for the individual study participant, the individual end of the study will be set to the time when the last AE resolved or stabilized if considered chronic or stabilized to the intensity before treatment. Data collection may be continued beyond the date of the follow-up examination, until maximal 4 weeks after treatment of the last study subject enrolled. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |