E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy |
Pazienti affetti da carcinoma prostatico che evidenzino progressione biochimica dopo trattamento chirurgico o radioterapico |
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E.1.1.1 | Medical condition in easily understood language |
Patients affected by prostate cancer previously treated with surgery or radiotherapy with suspected disease recurrence |
Ripresa di malattia nel carcinoma prostatico |
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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 | 20.0 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038604 |
E.1.2 | Term | Reproductive system and breast disorders |
E.1.2 | System Organ Class | 10038604 - Reproductive system and breast disorders |
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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 |
The aim of this study was firstly to assess the diagnostic performance of fused 64CuCl2-PET/MRI in patients with suspected relapse of prostate cancer after surgery or EBRT. In addition we want to compare the accuracy of fused 64CuCl2-PET/MRI with that of mMRI,18F-Choline-PET/MRI, 18F-Choline-PET/CT, and contrast enhanced CT in detecting local recurrence, lymph node, and bone metastases |
L’obiettivo primario dello studio è verificare l’efficacia della 64CuCl2 PET/RM (test sperimentale) rispetto alla 18F-Colina PET/TC, alla 18F-Colina PET/RM e alle metodiche di imaging radiologico quali TC con mdc e RM (test standard) nell’individuazione precoce di ripresa di malattia. Verrà calcolata la sensibilità, la specificità, il valore predittivo negativo, il valore predittivo positivo e l'accuratezza diagnostica della metodica 64CUCl2 PET/RM e confrontata con quella relativa alle altre metodiche diagnostiche tradizionali nello stesso gruppo di pazienti. In particolare verranno confrontati i risultati della 64CuCl2 PET/RM con quelli della 18F-Colina PET/TC e della 18F-Colina PET/RM. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives:
-to assess whether 64CuCl2-PET/MRI could eventually influence patient management, treatment decisions and outcome in comparison with all available data. Of course all patients will be followed up and treated independently by 64CuCl2-PET/MRI results;
-to test the association between 64CuCl2-PET/MRI detection rate, PSA level and Gleason score;
-to assess the association between the standard uptake value (SUV-max) of 64CuCl2-PET and apparent diffusion coefficient (ADC) value of local recurrence and lymph node metastases;
-To assess and compare the diagnostic performance of 3 further acquisitions of 64CuCl2 PET/CT;
-To acquire new information and refine the safety profile of 64CuCl2 for the execution of PET/CT diagnostics;
-To study the kinetic profile of 64CuCl2.
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-Valutare in quanti pazienti sarebbe stato cambiato il management clinico-terapeutico in base alla metodica diagnostica;
-Verificare la correlazione dei risultati della PET/RM con i livelli di PSA e il Gleason score;
-Verificare la correlazioni tra le SUV-max dei traccianti e il valore di ADC (Coeff. di Diffusione
Apparente) della RMM;
-Confrontare risultati in termini di sensibilità, la specificità, il valore predittivo negativo, il valore
predittivo positivo e l'accuratezza di ulteriori 3 acquisizioni 64CuCl2 PET/CT;
-Approfondire il profilo di sicurezza della somministrazione di 64CuCl2 per l’esecuzione di esame PET/CT diagnostico;
-Valutare la cinetica del 64CuCl2. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-years > 18 (no upper age limit)
-all histologically proven prostate cancer patients who showed biochemical relapse after surgery or first-line treatment with radiotherapy
-Gleason score ≥6,
-increasing levels of PSA and PSA doubling time (DT) ≤6 months.
-Informed consent available
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-età superiore a 18 anni (nessun limite superiore di età)
-pazienti operati o già trattati con brachi/radioterapia per carcinoma prostatico.
-diagnosi istologica di carcinoma prostatico
-Gleason score > 6
- livelli di PSA in aumento (tempo di raddoppiamento inferiore ai 6 mesi)
- rilascio del consenso informato scritto |
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E.4 | Principal exclusion criteria |
-comorbidity for other neoplasms
-inability to perform MRI
-known hypersensitivity to the substances or excipients contained in the tracers and contrast agent
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-comorbilità per altre neoplasie
- nota impossibilità ad eseguire esame dì Risonanza Magnetica
- nota ipersensibilità a principio attivo o eccipienti contenuti nei traccianti e nel mdc
- ogni altra condizione medica che controindichi lo studio a giudizio dello sperimentatore. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point is to evaluate the accuracy defined as: (True Negative + True Positive)/(True Negative + True Positive + False Negative + False Positive) = (Number of correct assessments)/Number of all assessments). |
L'end point primario dello studio è quello di valutare l'accuratezza definita come il rapporto fra la somma dei veri negativi e dei veri positivi sul totale dei pazienti. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. The secondary end point is to evaluate the specificity defined as: True Negative/(True Negative + False Positive) = (Number of true negative assessment)/(Number of all negative assessment)
2. The secondary end point is to evaluate the positive predictive value (PPV) defined as: True positive/(True positive+ False positive).
3. The secondary end point is to evaluate the negative predictive value (NPV) defined as: True negative/(True negative+ False negative).
4. The secondary end point is to evaluate the sensitivity defined as: True Positive/(True Positive + False Negative) = (Number of true positive assessment)/(Number of all positive assessment)
5. Assess and compare the sensitivity, specificity, PPV, NPV and accuracy as defined above, considering further PET / CT exams performed after 4 and 24 hours from baseline
6. Safety endpoints will be: blood pressure, heart and respiratory rate, signs and symptoms, blood tests (blood count, C-reactive protein, transaminases and gamma GT, ALP, creatinine and nitrogen) and glucose by glucometer.
7. kinetics endpoints will be:
- The absorbed dose by determining the volume of interest (VOI) of the relevant internal body areas using co-registered PET / CT images at 90 minutes and at 4 and 24 hours from injection.
- The masses and the cumulative activity for the internal body areas involved. |
1. Specificità inteso comera pporto fra soggetti negativi al test sperimentale (Ts-) e i veri negativi (VN)
2. Valore predittivo positivo (VPP): rapporto fra VP e la totalità dei soggetti positivi al test sperimentale (T+)
3. Valore predittivo negativo (VPN): rapporto fra VN e la totalità dei soggetti negativi al test sperimentale (T-)
4. Sensibilità intesa come il rapporto fra soggetti positivi al test sperimentale (Ts+) e i veri positivi (VP)
5. Valutare e confrontare sensibilità, specificità, VPP, VPN e accuratezza come definiti sopra, considerando le ulteriori esami PET/CT dopo 4 ore e a 24 ore dal tempo zero
6. endpoints di sicurezza saranno: pressione arteriosa, frequenza respiratoria e cardiaca, segni e sintomi, esami ematici (emocromo, proteina C reattiva, transaminasi e gamma GT, ALP, creatinina, azoto) e glicemia mediante glucometro.
7. Endpoints di cinetica di assorbimento saranno:
- la dose assorbita mediante determinazione dei volumi di interesse (VOI) degli organi interessati utilizzando immagini co-registrate PET/CT sia a 90' che a 4 e 24 ore dall'iniezione.
- le masse e l’attività cumulata per gli organi interessati.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 12 months
2. 12 months
3. 12 months
4. 12 months
5. 12 months
6. baseline, 7 and 24 hours after the first IMP administration
7. 90 minutes, 4 and 24 hours from injection. |
1. 12 mesi
2. 12 mesi
3. 12 mesi
4. 12 mesi
5. 12 mesi
6. alla visita basale e dopo 7 e 24 ore dalla prima somministrazione
7. 90 minuti, 4 e 24 ore dopo l'iniezione |
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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 | 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 |
to assess whether 64CuCl2-PET/MRI could eventually influence patient management |
Impatto clinico eventuale |
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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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Studio pilota di confronto tra metodiche diagnostiche nello stesso gruppo di pazienti. |
pilot study comparing different diagnostic methods in the same group of patients. |
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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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Information not present in EudraCT |
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 | 0 |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 30 |
E.8.9.2 | In all countries concerned by the trial days | 0 |