Etude : ARCHES /



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Acronyme
Nom
Traitement
Dernière MÀJ
Présentation de l'étude
Acronyme : ARCHES

Nom :

Traitement : Métastasique ou localement avancé

Dernière MÀJ : 25/09/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude multinationale de phase III, randomisée, en double aveugle, contrôlée contre placebo évaluant l'efficacité et la tolérance de l'enzalutamide + traitement par suppression androgénique (TSA) VERSUS placebo + TSA, chez des patients atteints d'un cancer de la prostate métastatique hormono-sensible (CPMHS)

Spécialité : Organes génitaux masculins
Localisation : C61 - Tumeur maligne de la prostate
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Etude randomisée, en double aveugle, groupes parallèles

2 arms:

- Experimental: Enzalutamide plus androgen deprivation therapy (ADT)
Subjects will receive enzalutamide once daily. ADT (either bilateral orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) will be maintained during study treatment as per standard of care (SOC) and provided by the site's pharmacy stock.

- Placebo Comparator: Placebo plus androgen deprivation therapy (ADT)
Subjects will receive matching placebo once daily. ADT (either bilateral orchiectomy or luteinizing hormone-releasing hormone (LHRH) agonist/antagonist) will be maintained during study treatment as per standard of care (SOC) and provided by the site's pharmacy stock.

Phase : III

Stade : IV

NA
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Subject is considered an adult according to local regulation at the time of signing informed consent.
- Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
- Subject has metastatic prostate cancer documented by positive bone scan or metastatic lesions on computed tomography (CT) or magnetic resonance imaging (MRI) scan. Subjects whose disease spread is limited to regional pelvic lymph nodes are not eligible.
- Once randomized at day 1, subject must maintain ADT with an LHRH agonist or antagonist during study treatment or have a history of bilateral orchiectomy (i.e., medical or surgical castration).
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Critères de non-inclusion : - Subject has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
1) Up to 3 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
2) Subject may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to day 1;
3) Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of day 1 and no evidence of disease progression during or after the completion of docetaxel therapy;
4) Up to 6 months of ADT with LHRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to day 1 if subject was treated with docetaxel, with no radiographic evidence of disease progression or rising PSA levels prior to day 1;
5) Prior ADT given for < 39 months in duration and > 9 months before randomization as neoadjuvant/adjuvant therapy.
- Subject had a major surgery within 4 weeks prior to day 1.
- Subject received treatment with 5-α reductase inhibitors (finasteride, dutasteride) within 4 weeks prior to day 1.
- Subject received treatment with estrogens, cyprotoerone acetate or androgens within 4 weeks prior to day 1.
- Subject received treatment with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to day 1.
- Subject received treatment with herbal medications that have known hormonal antiprostate cancer activity and/or are known to decrease PSA levels within 4 weeks prior to day 1.
- Subject received prior aminoglutethimide, ketoconazole, abiraterone acetate or enzalutamide for the treatment of prostate cancer or participation in a clinical study of an investigational agent that inhibits the AR or androgen synthesis (e.g., TAK-700, ARN-509, ODM-201).
- Subject has known or suspected brain metastasis or active leptomeningeal disease.
- Subject has absolute neutrophil count < 1500/μL, platelet count < 100000/μL or hemoglobin < 10 g/dL (6.2 mmol/L).
- Subject has total bilirubin (TBL) ≥ 1.5 x the upper limit of normal (ULN) (except subjects with documented Gilbert's disease), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 x the ULN .
- Subject has creatinine > 2 mg/dL (177 μmol/L)
- Subject has albumin < 3.0 g/dL (30 g/L).
- Subject has a history of seizure or any condition that may predispose to seizure.
- Subject has history of loss of consciousness or transient ischemic attack within 12 months prior to day 1.
- Subject has clinically significant cardiovascular disease.
- Subject received bisphosphonates or denosumab within 2 weeks prior to day 1 unless administered at stable dose or to treat diagnosed osteoporosis
NCT
Promoteur
Contact ARC
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
ASTELLAS
Type de sponsor : Industriel
ASTELLAS
00000 HORS FRANCE

Contact ARC :

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
Type d'étude
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Florence JOLY

TEC / ARC / IDE :
Astrid LETIEMBRE
a.letiembre@
baclesse.unicancer.fr

Ouverture de l'essai : CLOS

Type d'étude : Hors ciblage moléculaire / Hors innovation thérapeutique
MAJ : 18/12/2017