E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Metastatic castration resistant prostate cancer |
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E.1.1.1 | Medical condition in easily understood language |
Prostate cancer with metastases that do not respond to suppression of testosterone |
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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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10062904 |
E.1.2 | Term | Hormone-refractory 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 |
Investigate 68Ga-NOTA-AE105 PET/CT for response evaluation of Radium-223 therapy in patients with metastatic castration resistant prostate cancer.
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E.2.2 | Secondary objectives of the trial |
Investigate 68Ga-NOTA-AE105 PET/CT for prognostication in patients with metastatic castration resistant prostate cancer treated with Radium-223 therapy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Metastatic castration resistant prostate cancer - Approved to receive Radium-223 therapy - Age ≥ 18 years - Written and oral consent
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E.4 | Principal exclusion criteria |
- Lack of communication skills, including inability to understand study protocol - Other known malignant disease - Severe claustrophobia - Known allergy towards the IMP - If a participant exhibits allergic reaction to the IMP, the participant will be excluded from further participation in the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Uptake of 68Ga-NOTA-AE105 in prostate cancer metastases in bone and soft tissue quantified as SUVmax and SUVmean (standardized uptake value) before treatment with Radium-223 and after two series of treatment. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
End point is evaluated from PET/CT scans performed within one hour post injection of 68Ga-NOTA-AE105 |
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E.5.2 | Secondary end point(s) |
- Overall survival (defined as time from first dose of Radium therapy to death of any cause) - Time to progression: Time from first dose of Radium therapy to progression defined as development of soft tissue metastases, generel deterioration (WHO performance score > 2) or progression of bone metastases (defined as increased skeletal involvement radiologically or occurrence of symptomatic skeletal-related event (defined as occurrence of new pathological fracture or spinal cord compression or lesion progression requiring external beam radiation therapy or surgical intervention) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
End poins are evaluated by clinical follow-up 12 months after inclusion of the last participant
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Response evaluation and prognostication |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
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 | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |