EUCTR2013-004879-13-DE进行中（未招募）1 期
a-RT; Phase II open-label study to evaluate the efficacy and safety ofRadium-223 dichloride in combination with external beam radiotherapy (EBRT) vs.EBRT alone in the treatment of advanced castration resistant prostatecarcinoma with limited bone metastases - a-RT
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 274
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
- •Eligible patients will conform to all of the inclusion criteria listed below:
- •1. Has provided written informed consent. Subjects must be able to understand and be willing to sign the written informed consent form (ICF). A signed ICF must be appropriately obtained prior to the conduct of the any trial- specific procedure. Enrollment (entry) in the study is defined as the signing of the informed consent.
- •2. Age = 18 and = 85 years
- •3. Patients with progressive castration resistant prostate cancer (CRPC) with 1-5 bone metastases for whom Radium-223 dichloride constitutes first-line cytostatic treatment
- •4. Primary tumor (and its local recurrence, if applicable) controlled by effective local treatment
- •5. If diagnosed, pelvic lymph node metastases controlled by effective local treatment
- •6. At least 1 not previously locally treated skeletal metastasis on bone scan without non-bone distant metastases (e.g. lung, liver, and/or brain metastases) and without pathologically enlarged lymph nodes above the pelvis
- •7. Progressive disease is defined either by:
- •- The appearance of new bone lesions. If progression is based on new lesion(s) on bone scan only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided; OR
- •- In the absence of new bone lesions by 2 consecutive increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA =5 ng/mL
- •8. Life expectancy of at least 6 months
- •9. Zubrod (WHO/ECOG) Performance Status (PS) 0 or 1
- •10. Adequate bone marrow, liver and renal function as assessed by the following laboratory
- •requirements to be conducted within 7 days prior to start of therapy:
- •- Hemoglobin > 10.0 g/dl
- •- Absolute neutrophil count (ANC) >1,500/µl
- •- Platelet count >100,000/µl
- •- Total bilirubin < 1.5 times the institutional upper limit of normal (ULN)
- •- ALT and AST < 2.5 x institutional upper limit of normal (ULN)
- •- Serum creatinine < 2 x upper limit of normal.
- •11. Patient has or has had symptoms (e. g. pain or micro-fractions) from bone metastases
- •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 137
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 137
排除标准
- •Excluded medical conditions:
- •1. More than 5 not previously locally treated bone metastases as diagnosed by bone scintigraphy;
- •2. Visceral or lymph node metastases above the pelvis as assessed by computed tomography (CT) (or other imaging modality)
- •3. History of HIV infection or chronic hepatitis B or C
- •4. Active clinically serious infections (> grade 2 NCI-CTC version 4.03)
- •5. History of organ allograft
- •6. Patients undergoing renal dialysis
- •7. Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study if not in complete remission for at least 5 years since date of diagnosis, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- •8. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
- •9. Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI)
- •10. Any other serious illness or medical condition, such as but not limited to:
- •- Cardiac failure New York Heart Association (NYHA) III or IV
- •- Crohn’s disease or ulcerative colitis
- •- Bone marrow dysplasia
- •11. Fecal incontinence
- •12. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
- •13. Known allergy to Radium-223 dichloride (i.e. to active substance or one of the constituents)
- •Excluded therapies and medications, previous and concomitant:
- •1. Anticancer chemo- or targeted therapy for CRPC (e.g. docetaxel or cabazitaxel)
- •2. Local relapse in previously irradiated osseous metastases
- •3. Major surgery within 4 weeks of study entry.
- •4. Systemic therapy with radionuclides (e.g., strontium-89, samarium-153,
- •rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bone metastases
- •5. Autologous bone marrow transplant or stem cell rescue within 4 months of study entry
- •6. Use of biologic response modifiers, such as G-CSF, within 3 week of study entry. [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however they may not be substituted for a required dose reduction.] [Patients taking chronic erythropoietin are permitted provided no dose adjustment is undertaken within 2 months prior to the study entry or during the study]
- •7. Investigational drug therapy outside of this trial during or within 4 weeks of study entry
研究者
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