E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Histologically proven prostate cancer with Gleason score =7 and PSA>=10ng/ml or Gleason score >=8 and any PSA level or cT2-T3 and any PSA level or any Gleason score and PSA>=20ng/ml and indication of prostactectomy, radiotherapy or systemic therapy |
Pazienti con cancro della prostata a rischio intermedio-alto (secondo la classificazione della NCCN versione 2.2013: PSA≥10ng/mL e Gleason score=7 o Gleason score≥8 con qualunque valore di PSA, o cT2c-T3 alla diagnosi iniziale con qualunque valore di PSA o PSA≥20ng/mL con qualunque valore di Gleason score), candidati ad intervento chirurgico di prostactectomiao radioterapia o terapia sistemica sulla scorta della stadiazione iniziale |
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E.1.1.1 | Medical condition in easily understood language |
Histologically proven prostate cancer with indication of prostactectomy, radiotherapy or systemic therapy |
Pazienti con cancro della prostata a rischio intermedio-alto candidati ad intervento chirurgico di prostactectomia o radioterapia o terapia sistemica sulla scorta della stadiazione iniziale |
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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 | 14.1 |
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 |
Verify whether the additional use of PET/CT with 18F-fluorocholine in the initial staging of prostate cancer improves the sensitivity in defining the loco-regional disease with respect to CT and bone scan. |
Verificare se l’impiego della PET/TC con 18F-fluorocolina nella stadiazione iniziale del cancro della prostata a rischio intermedio-alto sia superiore in termini di sensibilità nel definire il coinvolgimento loco-regionale e sistemico della malattia nei confronti dell’imaging convenzionale (TC addome-pelvi con mezzo di contrasto e scintigrafia scheletrica). |
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E.2.2 | Secondary objectives of the trial |
To show whether the use of PET / CT with 18F-fluorocholine modifies the therapeutic approach regarding the use of surgical treatment and / or systemic therapy, evaluate the toxicity of 18F-fluorocholine and the cost-effectiveness of the additional use of PET / CT with 18F-fluorocholine. |
1) verificare se l’impiego di PET/TC con 18F-fluorocolina modifichi l’approccio terapeutico relativamente all’utilizzo del trattamento chirurgico locale e/o della terapia sistemica, 2) valutare la tossicità della 18F-fluorocolina e 3) il rapporto costo-efficacia dell’utilizzo aggiuntivo della metodica PET/TC con 18F-fluorocolina rispetto l’imaging convenzionale (TC e BS). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Histologically proven prostate cancer with Gleason score =7 and PSA>=10ng/ml or Gleason score >=8 and any PSA level or cT2-T3 and any PSA level or any Gleason score and PSA>=20ng/ml
Age more than 18 years |
Diagnosi istologica di cancro della prostata a rischio intermedio-alto Età >=18 anni
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E.4 | Principal exclusion criteria |
Metastatic disease
Patients treated with anti-androgen therapy or radiotherapy
Previous malignancy |
Metastasi linfonodali loco-regionali o a distanza già note Precedente terapia sistemica o radioterapia Precedente neoplasia maligna
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E.5 End points |
E.5.1 | Primary end point(s) |
sensitivity of PET/TC 18F-fluorocholine in defining the loco-regional disease |
Sensibilità della PET/TC 18F-fluorocolina nell’individuare i linfonodi metastatici |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 180 days since randomization |
fino a 180 giorni dalla randomizzazione |
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E.5.2 | Secondary end point(s) |
1) number of patients undergoing surgery or systemic therapy in each study arm 2) toxicity measured with the National Cancer Institute Common Terminology Criteria for Adverse Events v4 System 3) costs of diagnostic methods and absolute risk reduction for a futile surgery obtained using PET/TC 18F-fluorocholine |
1) numero di pazienti sottoposti a intervento chirurgico o terapia sistemica in ciascun braccio di studio 2) tossicità misurata con il sistema National Cancer Institute Common Terminology Criteria for Adverse Events v4 3) media delle tariffe dei metodi diagnostici impiegati definite dai Tariffari Regionali e riduzione assoluta del rischio di essere sottoposto ad una chirurgia inutile definita come intervento chirurgico in pazienti con metastasi a distanza e intervento di linfoadenectomia estesa in pazienti con malattia linfonodale limitata od assente
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 180 days since randomization |
fino a 180 giorni dalla randomizzazione |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
imaging convenzionale |
standard imaging |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |