EUCTR2018-000899-15-PL进行中（未招募）1 期
Radiotherapy and 6-month androgen deprivation therapy with or without apalutamide in Intermediate and Limited High Risk Localized Prostate Cancer: a phase III study
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 990 人开始时间: 2020年1月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 990
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
- •Histologically confirmed diagnosis of prostate adenocarcinoma diagnosed by ultrasound guided biopsy of the prostate containing 10-12 cores showing no neuroendocrine component at local institution. (An MRI-fusion biopsy is allowed if taken because a previous biopsy was negative.)
- •PSA - Favorable intermediate risk :
- •- Only one of the following intermediate risk factors: PSA 10-20 ng/mL, or Gleason score 7 (3+4) (international society of urological pathology-ISUP Grade 2), or cT2b
- •- Unfavorable intermediate risk :
- •- either PSA 10-20 ng/mL and cT2b,
- •- or Gleason score 7 (4+3) (ISUP Grade 3)
- •- Limited high risk: 20 ng/mL or Gleason score >7 (ISUP Grade 4/5)
- •M0 by standard imaging work-up
- •Scheduled to be treated with primary prostate RT
- •ECOG/WHO Performance Status = 2
- •The following laboratory values done within 4 weeks before randomization:
- •- aspartate aminotransferase (AST), alanine aminotransferase (ALT), <2.5 x upper limit of normal (ULN)
- •- 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]
- •- creatinine level < 2 x ULN
- •- serum albumin = 3.0 g/dL
- •- serum potassium = 3.5 mmol/L
- •- hemoglobin = 10.0 g/dL (independent of transfusion and/or growth factors within 3 months prior to randomization)
- •- platelet count = 100 x 109/L (independent of transfusion and/or growth factors within 3 months prior to randomization)
- •Age = 18 years and = 80 years
- •Be able to swallow whole study drug tablets
- •Patients with partners of childbearing / reproductive potential should agree to use a condom plus a highly effective method of birth control while on study drug and for at least 3 months following the last dose of study treatment. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly. Patients must also agree not to donate sperm during the study and for 3 months after receiving the last dose of study treatment.
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •Central pathology review on slides obtained at diagnosis for quality assurance purpose will be done.
- •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 743
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 247
排除标准
- •cT2c, T3, T4 or pelvic lymph nodes involvement, as assessed by CT scan or MRI (cN1) or pelvic lymph node dissection (pN1)
- •Previous pelvic irradiation or radical prostatectomy.
- •Bilateral orchiectomy
- •Prior systemic (e.g., chemotherapy) or procedural (e.g., prostatectomy, cryotherapy) treatment for prostate cancer
- •Prior treatment with 5-alpha reductase inhibitors for benign prostatic hypertrophy not discontinued 4 weeks prior to randomization
- •Prior treatment with any LHRH agonist or antagonist, bicalutamide, flutamide or nilutamide, enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer
- •Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy for prostate cancer
- •Other malignancy except adequately treated basal cell carcinoma of the skin or other malignancy from which the patient has no evidence of disease for at least 5 years.
- •History of Ulcerative Colitis, Crohn's Disease, Ataxia Telangiectasia, systemic lupus erythematosus or Fanconi anemia
- •History of seizure or condition that may predispose to seizure (including but not limited to: a) prior stroke, transient ischemic attack or loss of consciousness, any of which occurred = 1 year prior to randomization; b) brain arteriovenous malformation; or c) intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect).
- •Medications known to lower the seizure threshold (see list under prohibited medication, section 5.4.4) must be discontinued or substituted at least 4 weeks prior to study entry
- •Certain risk factors for abnormal heart rhythms/QT prolongation: torsade de pointes ventricular arrhythmias (e.g., heart failure, hypokalemia, or a family history of a long QT syndrome), a QT or corrected QT (QTc) interval > 450 ms at baseline
- •Uncontrolled hypertension (systolic BP = 140 mmHg or diastolic BP = 90 mmHg); patients with a history of hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment
- •Bilateral hip prostheses
- •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 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
- •Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or LHRH agonists or any of the components of the formulations
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
研究者
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