EUCTR2013-003046-17-DE进行中（未招募）1 期
A re-treatment safety study of radium-223 dichloride in subjects with castration-resistant prostate cancer with bone metastases who received an initial course of six doses of radium-223 dichloride 50 kBq/kg every four weeks
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 40
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 or cytologically confirmed adenocarcinoma of the prostate at any given point in time during disease history
- •- CRPC (castration-resistant prostate cancer) with clinical or radiologically confirmed bone progression
- •- Treatment with 6 injections of radium-223 dichloride 50 kBq/kg and no evidence of progression to bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) during the first course of treatment
- •- Re-treatment with radium-223 dichloride is indicated based on one or
- •more of the following:
- •o Radiological progression (according to PCWG2 criteria) in bone after the initial course of radium-223 dichloride treatment or
- •o Clinical progression defined as:
- •- Confirmed rising PSA (2 subsequent values showing PSA increase [a minimum value of 2 ng/mL {µg/L}], at least 1 week apart) after the initial course of radium-223 dichloride treatment or
- •- Substantial worsening of pain after the initial course of radium-223 dichloride treatment, based on the investigator’s determination. This pain should be due to the existing bone metastasis.
- •- Signed written informed consent prior to participating in any study related procedures. Willing and able to comply with the protocol, including follow-up visits and examinations
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- History of a radium-223 dichloride-related serious adverse event (SAE) or CTCAE Grade 3 or 4 adverse event (AE) during or after the initial course of radium-223 dichloride treatment that led to the discontinuation of treatment
- •- Less than 30 days from the last dose administered in the initial course of radium-223 dichloride treatment
- •- Visceral metastases 1 cm or greater in largest diameter and / or requiring local or systemic therapeutic intervention, as assessed by abdominal and pelvic magnetic resonance imaging (MRI) / computed tomography (CT) scan and / or chest X-ray within 30 days of the start of treatment
- •- Lymphadenopathy with lymph nodes exceeding 6 cm in short-axis diameter and / or requiring local or systemic therapeutic intervention. Enlarged lymph nodes of any size if the lymphadenopathy is thought to be a contributor to concurrent hydronephrosis
- •- Current central nervous system (CNS) metastases
- •- Chronic conditions associated with non-malignant abnormal bone growth (e.g., confirmed Paget’s disease of bone)
- •- Treatment with chemotherapy after the initial course of radium-223 dichloride treatment
- •- Prior hemibody external radiotherapy
- •- Prior systemic radiotherapy with strontium-89, samarium-153, rhenium-186, or rhenium-188
- •- Any other serious illness or medical conditions
- •-- Crohn’s disease or ulcerative colitis
- •-- History of documented bone marrow dysplasia
- •-- Unmanageable fecal incontinence
- •- Imminent or established spinal cord compression based on clinical findings and / or MRI that has not yet been treated
- •- Other malignancy treated within the last 3 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
研究者
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