E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced/metastatic solid tumors |
tumori solidi avanzati o metastatici |
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E.1.1.1 | Medical condition in easily understood language |
advanced/metastatic solid tumors |
tumori solidi avanzati o metastatici |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10027477 |
E.1.2 | Term | Metastatic carcinoma |
E.1.2 | System Organ Class | 100000004864 |
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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 primary objective of this study is to evaluate the detection rate of 68Ga-PSMA PET/CT, defined as the ratio of 68Ga-PSMA-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a 68Ga-PSMA PET/CT as part of the present study. A positive patient is defined as a patient with at least one 68Ga-PSMA-positive lesion. |
L'obiettivo primario di questo studio è quello di valutare la positività alla PET/CT con 68Ga-PSMA, definita come il rapporto tra pazienti 68Ga-PSMA-positivi e il numero totale dei pazienti con malattia avanzata / metastatica nota sottoposti a 68Ga-PSMA PET / TC nell'ambito del presente studio.
Un paziente 68Ga-PSMA-positivo è definito come un paziente con almeno una lesione 68Ga-PSMA-positiva.
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E.2.2 | Secondary objectives of the trial |
Safety;
Lesions detection rate stratified per tumour histotypes;
Lesions detection rate stratified for different lesion sites;
To evaluate patients’eligibility for 177Lu-PSMA therapy;
To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy;
Reduce kidney uptake with diuretic treatment.
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Sicurezza;
tasso di rilevamento delle lesioni, stratificate per istotipi tumorali;
tasso di rilevamento delle lesioni stratificate per diversi siti di lesione;
valutazione dell’eleggibilità del paziente al trattamento con 177Lu-PSMA;
valutazione dei cambiamenti nell’assorbimento del 68Ga-PSMA nei pazienti sottoposti a terapia con farmaci anti-angiogenici;
Riduzione dell’assorbimento renale con terapia diuretica
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with mCRPC or advanced/metastatic solid tumors;
2. Relapse or progression disease on CT scan and / or MR;
3. Age ≥ 18 years;
4. Written informed consent
5. ECOG performance status ≤2
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Pazienti con mCRPC o tumori solidi avanzati / metastatici;
2. Pazienti con ricaduta o progressione di malattia alla TAC e / o RM;
3. Età ≥ 18 anni;
4. consenso informato scritto
5. ECOG performance status ≤2
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E.4 | Principal exclusion criteria |
1. Pregnancy / Nursing;
2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA or other agents used in the study.
3. inability to remain still for the entire duration of the exam
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1. Gravidanza/allattamento
2. Storia di reazioni allergiche attribuite a composti chimicamente o biologicamente simili al 68Ga-PSMA p ad altri agenti usati nello studio
3. incapacità di restare fermo per tutta la durata dell'esame |
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E.5 End points |
E.5.1 | Primary end point(s) |
detection rate of the 68Ga-PSMA PET/CT in mCRPC or advanced/metastatic cancer patients, defined as the proportion of 68Ga-PSMA- positive patients and the total number of recruited patient |
valutare la positività alla PET/CT con 68Ga-PSMA, definita come il rapporto tra pazienti 68Ga-PSMA-positivi e il numero totale dei pazienti con malattia avanzata / metastatica nota sottoposti a 68Ga-PSMA PET / TC nell'ambito del presente studio |
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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) Safety
2) Lesions detection rate stratified per tumour histotypes
3) Lesions detection rate stratified for different lesion sites
4) To evaluate patients’ eligibility for 177Lu-PSMA therapy
5) To evaluate changes in 68Ga-PSMA uptake in patients on anti-angiogenetic therapy
6) Reduce kidney uptake with diuretic treatment |
1) Sicurezza
2) tasso di rilevamento delle lesioni, stratificate per istotipi tumorali
3) tasso di rilevamento delle lesioni stratificate per diversi siti di lesione
4) valutazione dell’eleggibilità del paziente al trattamento con 177Lu-PSMA
5) valutazione dei cambiamenti nell’assorbimento del 68Ga-PSMA nei pazienti sottoposti a terapia con farmaci anti-angiogenici
6) Riduzione dell’assorbimento renale con terapia diuretica |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 36 months
2) 36 months
3) 36 months
4) 36 months
5) 36 months
6) 36 months |
1) 36 mesi
2) 36 mesi
3) 36 mesi
4) 36 mesi
5) 36 mesi
6) 36 mesi |
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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 | 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 | No |
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 | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |