EUCTR2015-003007-38-IT进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy - ATLAS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •- Age >= 18 years
- •- Indicated and planned to receive primary radiation therapy for prostate cancer
- •- Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis:
- •1) Gleason score >=8 and >=cT2c stage per AJCC 8th Edition,
- •2) Gleason score >=7, PSA >=20 nanogram per mililiters (ng/mL), and >=cT2c stage per AJCC 8th Edition
- •- Charlson comorbidity index (CCI) <=3
- •- An Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) grade of 0 or 1
- •- Adequate organ function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2 * within limit of normal (ULN).
- •- total bilirubin WNL
- •- Serum Creatinine <1.5 mg / dL (<133 µmol / L)
- •- Platelets> = 140,000 / µL, independent of transfusion and / or growth factors within 3 months before randomization
- •- Hemoglobin> = 12.0 g / dL (7.4 mmol), independent of transfusion and / or growth factors within 3 months before randomization
- •- Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
- •- Signed, written, informed consent
- •- Be able to swallow whole study drug tablets
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
排除标准
- •- Presence of distal metastases (clinical stage M1). Pelvic nodal disease isolated under the iliac bifurcation (clinical
- •stage N1) is not an exclusion. The diagnosis of distal metastases (clinical M stage; M0 versus M1a, M1b, M1c) and
- •pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological examination. Patients
- •are considered eligible only if the central radiological examination confirms the clinical stage M0.
- •- Prior treatment with GnRH analogue or antiandrogen or both for >3 months prior to randomization
- •- Bilateral orchiectomy
- •- History of pelvic radiation
- •- Prior systemic (eg, chemotherapy) or local (eg, prostatectomy, cryotherapy) treatment for prostate cancer
- •- History of seizure or any other 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)
- •- Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer (cyproterone acetate included)
- •- 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-alpha 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
- •- Current or prior treatment with antiepileptic medications for the treatment of seizures
- •- Gastrointestinal conditions affecting absorption
- •- Known or suspected contraindications or hypersensitivity to Apalutamide, 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
研究者
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