E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Men with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification |
Uomini con conferma istopatologia di tumore prostatico a rischio intermedio o alto, secondo le linee guida PCa EAU del 2019 |
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E.1.1.1 | Medical condition in easily understood language |
Men with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification |
Uomini con conferma istopatologia di tumore prostatico a rischio intermedio o alto, secondo le linee guida PCa EAU del 2019 |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036927 |
E.1.2 | Term | Prostate neoplasia |
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 |
To evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extra-prostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at intermediate or high-risk. |
Valutare l'accuratezza diagnostica della PET/CT con [68Ga]Ga-PSMA-11 nel rilevamento del tumore primario ed extra prostatico (linfonodo, diffusione nei tessuti molli o metastasi ossee) in uomini con nuova diagnosi di neoplasia prostatica a rischio intermedio o alto. |
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E.2.2 | Secondary objectives of the trial |
To compare the diagnostic accuracy of [68 Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or without CT of the lower abdomen and bone scan) in the prostatic bed and extra prostatic disease in men newly diagnosed with prostate cancer at intermediate or high-risk. To evaluate correlation between PET PSMA uptake value (SUVmax and SUVmean) and aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score). |
Confrontare l'accuratezza diagnostica della PET/CT con [68Ga]Ga-PSMA-11 con l'accuratezza diagnostica delle tecniche di imaging convenzionale mpMRI (con o senza CT del basso addome e scintigrafia ossea) nel rilevamento del tumore primario ed extra prostatico in uomini con nuova diagnosi di neoplasia prostatica a rischio intermedio o alto. Valutare la correlazione tra i parametri metabolici della PET/CT (SUV max e SUV mean) e la aggressività del tumore (definita mediante il Gleason Score, i livelli sierici di PSA, il volume del tumore). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
In order to be eligible to participate in this study, a subject must meet all of the following criteria: I. Patients with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph) II. Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer EAU Guidelines III. Age >18 years/old IV. Ability to provide written informed consent |
Per poter partecipare a questo studio, un paziente deve soddisfare tutti i seguenti criteri: I. Pazienti con conferma istopatologia di tumore prostatico a rischio intermedio o alto, in accordo alle Linee Guida “Prostate Cancer EAU Guidelines Risk Group Stratification (2019)” II. Pazienti sottoposti a Risonanza Magnetica multiparametrica (mpMRI) dell'addome inferiore (accompagnata o no da Tomografia computerizzata a raggi X (TC) e scintigrafia ossea con [99mTc]Tc-HMDP) per la stadiazione iniziale di tumore prostatico, in accordo alle Linee Guida “Prostate Cancer EAU Guidelines Risk Group Stratification (2019)” III. Pazienti di età superiore ai 18 anni IV. Pazienti in grado di fornire il consenso informato per iscritto |
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E.4 | Principal exclusion criteria |
Patients who meet one of the following criteria: I. Contra-indication for PET/CT scan: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam II. Impaired renal function III. Impaired liver function: AST or ALT > 2.5 x ULN IV. Patients unable to understand the purpose of the study V. Medical history of allergic reactions or hypersensitivity to [68Ga] Ga-PSMA-11 as well as to any excipient or component of the experimental medicinal product VI. Having partecipated in clinical trial in which the experimental intervention was administered within 30 days (or 5 half-life) from administration the endovenous solution of [68Ga]Ga-PSMA-11 |
Pazienti che soddisfano uno dei seguenti criteri: I. Controindicazione all’esame PET/TC: pazienti non in grado di eseguire uno studio PET a causa del peso, della claustrofobia o dell'incapacità di rimanere fermi per tutta la durata dell'esame II. Pazienti con funzione renale alterata III. Pazienti con funzione epatica alterata: AST o ALT > 2.5 x ULN IV. Pazienti incapaci di comprendere lo scopo dello studio V. Anamnesi di reazioni allergiche o ipersensibilità al principio attivo, a uno qualsiasi degli eccipienti o a uno qualsiasi dei componenti del radiofarmaco marcato VI. Partecipazione ad uno studio clinico in cui è stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite prima del farmaco in studio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Diagnostic Accuracy Measures will be estimated as well as their 95% confidence interval. For the primary objective, the following index test and reference test will be considered: Index test: [68Ga]Ga-PSMA-11 PET/CT performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months follow-up and up to 24 months after treatment. Two nuclear medicine physicians will review the PET images using PET/CT Software Syngo.via independently. PET images will be reviewed for identification of focal [68Ga]Ga-PSMA-11 PET/CT uptake within and outside the prostate. A PET positive finding in prostate gland is defined with PSMA equal to or above liver and lower than parotid gland. A PET positive finding for pelvic or retroperitoneal lymph nodes or lymph nodes = 8mm is defined with PSMA uptake equal to or above blood pool and lower than liver. A PET positive finding in lymph nodes of other regions is defined with PSMA uptake equal to or above liver and lower than parotid gland. Any uptake equal to or above parotid gland will be considered positive. [28]. The readers will be blinded to clinical and pathologic data, except for the knowledge of diagnosis of biopsy-proven prostate cancer. |
L'accuratezza diagnostica sarà valutata con un intervallo di confidenza del 95%. Per l'obiettivo primario, verranno considerati i seguenti test indice e test di riferimento: Test indice: PET/TC con [68Ga] Ga-PSMA-11 PET / CT eseguita prima del trattamento. Test di riferimento: valutazione clinica, radiologica e isto-patologica, se disponibile, a 12 mesi di follow-up e fino a 24 mesi dopo il trattamento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 24 months after treatment |
Fino a 24 mesi dopo il trattamento |
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E.5.2 | Secondary end point(s) |
For the secondary objective, the following index test and reference test will be considered: Index test: conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed before treatment Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months follow-up and up to 24 months after treatment. MRI imaging results will be evaluated by two radiologists specializing in body MRI imaging with the PI-RADS version 2 criteria (21). In addition, for the secondary objective, after testing the assumption of normality with the Kolmogorov-Smirnov test, the metabolic PET parameters (SUV max and SUV mean) will be correlated with PSA serum level, by using the Pearson correlation, and with Gleason score and tumor volume, by using the Spearman correlation. The SUV of [68Ga]Ga-PSMA-11 will be calculated according to the following formula: (measured activity concentration [MBq/mL] * body weight [g]) / injected activity [MBq]. The SUV max and SUV mean of [68Ga]Ga-PSMA-11 will be evaluated, both for prostate gland suspected lesion and distant suspected localizations. |
Per l'obiettivo secondario, saranno presi in considerazione i seguenti test indice e test di riferimento: Test indice: mpMRI (con o senza TC dell'addome inferiore e scansione ossea) eseguita prima del trattamento Test di riferimento: valutazione clinica, radiologica e isto-patologica, se disponibile, a 12 mesi di follow-up e fino a 24 mesi dopo il trattamento.
Inoltre, per l'obiettivo secondario, i parametri metabolici della PET (SUV max e media SUV) saranno correlati con il livello sierico di PSA, usando la correlazione di Pearson, e con il Gleason Score e il volume del tumore, usando la correlazione di Spearman. Il SUV del [68Ga] Ga-PSMA-11 sarà calcolato secondo la seguente formula: (concentrazione dell'attività misurata [MBq / mL] * peso corporeo [g]) / attività iniettata [MBq]. Verranno valutati il SUVmedio il SUVmax del [68Ga] Ga-PSMA-11, sia per le sospette lesioni della ghiandola prostatica sia per le sospette localizzazioni extraprostatiche |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 24 months after treatment |
Fino a 24 mesi dopo il trattamento |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Studio interventistico, monocentrico, in aperto, a singolo braccio, prospettico di accuratezza diagn |
Diagnostic accuracy prospective, single-centre, open-label, single group assignment, interventional |
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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.8.2.4 | 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.8.6 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 | 4 |
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 | 4 |
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 |