CTIS2023-505246-26-00进行中（未招募）1 期
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 - 56021927PCR3003
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,315
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 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 determined by the following central laboratory values: 1) aspartate aminotransferase (AST), alanine aminotransferase (ALT) within normal limits (WNL) 2) total bilirubin WNL 3) Serum creatinine <1.5 mg/dL (<133 µmol/L) 4) Platelets =140,000/µL, independent of transfusion and/or growth factors within 3 months prior to randomization 5) Hemoglobin = 12.0 g/dL (7.4 mmol), independent of transfusion and/or growth factors within 3 months prior to 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
排除标准
- •- Presence of distant metastasis (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0, - 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, - Prior treatment with GnRH analog or antiandrogen or both for >3 months prior to randomization, - Bilateral orchiectomy, - History of pelvic radiation, - Prior systemic (eg, chemotherapy) or local (eg, radical prostatectomy, cryotherapy) treatment for prostate cancer, - History of seizure or any 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 (including cyproterone acetate) 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 subject expected to require long-term use of corticosteroids during the study
研究者
相似试验
进行中（未招募）
1 期
A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMedDRA version: 20.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 100000004864EUCTR2012-000600-15-PTJanssen-Cilag International NV580
进行中（未招募）
1 期
A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.EUCTR2012-000600-15-GBJanssen-Cilag International NV578
进行中（未招募）
1 期
A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMedDRA version: 14.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-000600-15-GRJanssen-Cilag International NV578
进行中（未招募）
1 期
A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaMedDRA version: 14.1 Level: LLT Classification code 10008976 Term: Chronic lymphocytic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2012-000600-15-ESJanssen-Cilag International NV580
进行中（未招募）
1 期
A Study of Ibrutinib in Combination with Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.EUCTR2012-000600-15-SEJanssen-Cilag International NV580