Essai Clinique Généré le 27 sept. 2021 à partir de
Titre Étude de phase III randomisée, à double insu et contrôlée par placebo, portant sur l’utilisation du JNJ-56021927 chez des sujets atteints d’un cancer de la prostate localisé ou localement avancé à risque élevé, qui reçoivent une radiothérapie primaire
Protocole ID CR106935
ClinicalTrials.gov ID NCT02531516
Type(s) de cancer Prostate
Phase Phase III
Stade Adjuvant
Type étude Traitement
Médicament JNJ-56021927
Institution CISSS DE L'OUTAOUAIS HOPITAL DE GATINEAU 909 Boulevard La Vérendrye, Gatineau, QC, J8P 7H2
Ville Gatineau
Investigateur principal Dr Robert Archambault
Coordonnateur Isabelle Laforest 819-966-6100 poste 3669
Statut Fermé
Date d'activation 08-10-2016
But étude The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival.
Critères d'éligibilité Each potential subject must satisfy all of the following criteria to be enrolled in the study. Subject must be a man ≥18 years of age Each subject must sign an informed consent form (ICF) indicating that he understands the purpose of and procedures required for the study and is willing to participate in the study. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol (Section 4.3). Indicated and planned to receive primary RT for prostate cancer. Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: Gleason score ≥8 and ≥cT2c Gleason score ≥7, PSA ≥20 ng/mL, and ≥cT2c Charlson comorbidity index (CCI) ≤3 (Attachment 1) An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1 (Attachment 2) Adequate liver function determined by the following central laboratory values: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 x upper limit of normal (ULN) and total bilirubin <1.5 x upper limit of normal (ULN) [NOTE: in subjects with Gilbert’s syndrome, if total bilirubin is >1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 x ULN, subject may be eligible] To avoid risk of drug exposure through the ejaculate (even men with vasectomies), subjects must use a condom during sexual activity while on study drug and for 3 months following the must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed during the Treatment Phase and for 3 months following the last dose of study drug. Be able to swallow whole study drug tablets
Critères d'exclusion Each potential subject must NOT satisfy any of the following criteria to be enrolled in the study. Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis Prior treatment with GnRH analogue or anti-androgen or both for >3 months prior torandomization Bilateral orchiectomy History of pelvic radiation Prior systemic (eg, chemotherapy) or procedural (eg, prostatectomy, cryotherapy) treatment for prostate cancer Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer Prior treatment with radiopharmaceutical agents (eg, strontium-89) or immunotherapy (eg, sipuleucel-T) for prostate cancer Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study Use of 5-α reductase inhibitors (eg, dutasteride, finasteride) ≤4 weeks prior to randomization Use of any investigational agent ≤4 weeks prior to randomization Current chronic use of opioid analgesics for ≥3 weeks for oral or ≥7 days for non-oral formulations Major surgery ≤4 weeks prior to randomization History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect). Current or prior treatment with anti-epileptic medications for the treatment of seizures Gastrointestinal conditions affecting absorption Known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject