E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
metastatic prostate cancer resistant to castration with visceral disease |
carcinoma della prostata metastatico resistente alla castrazione con malattia viscerale |
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E.1.1.1 | Medical condition in easily understood language |
Metastatic castration resistant prostate cancer previously treated with hormonal treatment/chemotherapy with at least one visceral site of disease (lung, liver, lymphnodes) |
carcinoma della prostata che ha già ricevuto un trattamento ormonale/chemioterapico con malattia metastatica in almeno una sede viscerale (polmone , fegato , linfonodi) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Male diseases of the urinary and reproductive systems [C12] |
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 | 10007453 |
E.1.2 | Term | Carcinoma of the prostate metastatic |
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 |
Clinical benefit, in terms of disease control at 3 months (DCR) of Enzalutamide in patients with cancer castration resistant prostate cancer with the presence ofvisceral disease |
Beneficio clinico, in termini di controllo di malattia a 3 mesi(DCR) di Enzalutamide in pazienti affetti da carcinoma della prostata metastatico resistente alla castrazione con presenza di malattia viscerale |
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E.2.2 | Secondary objectives of the trial |
Evaluate the safety profile of the treatment; Assess the quality of life through specific questionnaires such as EQ-5D-5L and FACT-P; Assess pain using the BPI-SF questionnaire |
Valutare il profilo di tollerabilità del trattamento; Valutare la qualità di vita attraverso specifici questionari quali: EQ-5D-5L e FACT-P; Valutare il dolore mediante il questionario BPI-SF. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetics Version: 1 Date: 27/10/2015 Title: A phase II study evaluating the efficacy of enzalutamide and the role of ARv7 in metastatic castration resistant prostate cancer (mCRPC) patients with visceral disease Objectives: To explore the association between AR-V7 splicing variants (in CTCs samples) and treatment response/resistance.
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Farmacogenetica Versione: 1 Data: 27/10/2015 Titolo: Studio di fase II per valutare l’efficacia di Enzalutamide e il ruolo di ARv7 in pazienti affetti da carcinoma della prostata metastatico resistente alla castrazione con malattia viscerale. Obiettivi: Verificare l’associazione tra la variante di splicing AR-V7 (determinatasui campioni di CTCs) e la risposta/resistenza al trattamento.
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E.3 | Principal inclusion criteria |
- Biopsy (primary tumour or metastases) confirming the diagnosis of prostate adenocarcinoma - Documented measurable metastatic visceral disease (according to RECIST 1.1 criteria) - Life expectancy > 3 months - Patients may have received previous therapy including chemotherapy (including docetaxel) - Progressive disease by PSA or imaging in the setting of medical or surgical castration. Disease progression for study entry is defined as one or more of the following three criteria (according with PCWG2) |
- Diagnosi istologica (tumore primitivo o metastasi) di adenocarcinoma della prostata - Almeno 1 lesione viscerale metastatica misurabile - Aspettativa di vita > 3 mesi - pazienti devono avere ricevuto un trattamento precedente ed essere in fase di resistenza alla castrazione. Possono avere ricevuto un trattamento chemioterapico contenente Docetaxel - Evolutività di malattia biochimica (PSA) e/o radiologica in accordo con i criteri PCWG2 |
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E.4 | Principal exclusion criteria |
- Metastases in the brain or active epidural disease - History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer - Prior treatment with abiraterone acetate - Treatment (concomitant or in the previous 2 weeks) with anti-androgens (eg. Bicalutamide, nilutamide, flutamide) or 5-a reductase inhibitors (eg. finasteride, dutasteride) |
- Metastasi cerebrali o meningee - Anamnesi di seconda neoplasia maligna nei 5 anni precedenti eccetto che per tumori della pelle non melanoma trattati radicalmente - Precedente trattamento con abiraterone -Trattamento attuale o pregresso nelle 2 settimane precedenti l’inizio del trattamento con il medicinale sperimentale con uno dei seguenti agenti per il carcinoma della prostata: Antiandrogeni (es. bicalutamide, nilutamide, flutamide) Inibitori della 5-a reduttasi (es. finasteride, dutasteride) |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is 3 months DCR |
L’endpoint primario è il controllo di malattia a 3 mesi |
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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) |
- To determine the safety of the treatment - to evaluate quality of life according EQ-5D-5L e FACT-P - to evaluate pain according to BPI-SF |
- Valutare il profilo di tollerabilità del trattamento - Valutare la qualità di vita attraverso specifici questionari quali: EQ-5D-5L e FACT-P - Valutare il dolore mediante il questionario BPI-SF. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
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 explore the association between AR-V7 splicing variants (in CTCs samples) and treatment response/resistance.
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Verificare l’associazione tra la variante di splicing AR-V7 (determinata sui campioni di CTCs) e la risposta/resistenza al trattamento |
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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 | 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 | 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
| 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 | 20 |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |