NCT02278055已完成2 期
Phase II Open, Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Percentage of Participants With 30% Decline in the Brief Pain Inventory (BPI) Worst Pain Item From Baseline to Week 8
研究概览
简要总结
The purpose of this study is to find out if Radium-223 is effective in reducing cancer pain within 12 weeks of treatment. In order to see if Radium-223 is effective, the patient's level of pain will be followed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males aged 18 years of age and above
- •Histological or cytological proof of prostate adenocarcinoma
- •Castrate serum testosterone level: ≤50 ng/dL (≤1.7 nmol/L)
- •Patients who have experienced disease progression despite initial hormonal therapy, either by orchiectomy or by using a GnRH agonist in combination with an anti-androgen, must first progress through anti- androgen withdrawal prior to being eligible. The minimum time frame to document failure of anti-androgen withdrawal will be four weeks. Patients on second-line (or beyond) hormonal maneuvers, and patients who had no PSA decline on combined androgen blockade as first line therapy, need not progress through AAW in order to be eligible.
- •Known progressive castration-resistant disease, defined as:
- •Serum PSA progression defined as two consecutive increases in PSA over a previous reference value within 6 months of first treatment, each measurement at least one week apart. Serum PSA at screening ≥ 2 ng/mL or
- •Documented appearance of new lesions by bone scintigraphy
- •ECOG Performance Status of 0-2 2 or more bone metastases demonstrated on bone scintigraphy
- •Pain at baseline as measured by a BPI worst pain score average of ≥
- •The BPI worst pain score average will be based on the worst pain scores completed by the patient in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the patient in the 7 day window in order to calculate the average worst pain score. The investigator will optimize the subject's pain regimen prior to study entry.
- •Normal organ function with acceptable initial laboratory values:
- •WBC ≥ 3 x 109 /L
- •ANC ≥ 1.5 x 109 /L
- •Platelets ≥ 100 x 109 /L
- •Hemoglobin ≥ 9.0 g/dL
- •Creatinine < 1.5 x institutional upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 x ULN
- •AST/ALT ≤ 2.5 x ULN
- •Albumin > 25 g/L
- •All acute toxicities as a result of any prior treatment must have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) [Note: Ongoing grade 2 neuropathy as a result of treatment with a cytotoxic chemotherapy regimen is permitted]
- •Life expectancy of at least 6 months
- •Willing and able to provide written informed consent and HIPAA authorization for the release of personal health information NOTE: HIPAA authorization may be either included in the informed consent or obtained separately
- •Willing and able to comply with the protocol, including follow-up visits, examinations as well as having the ability to self-report pain and fatigue using a Patient Reported Outcome (PRO) instrument
- •Willingness to use adequate methods of contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug
排除标准
- •Prior exposure to Radium-223
- •Received an investigational therapy within the 4 weeks prior to registration or is scheduled to receive one during the treatment period
- •Received a new anti-cancer agent within 4 weeks prior to registration
- •Received external beam radiotherapy within 4 weeks prior registration
- •Received systemic therapy with radionuclides (e.g. strontium-89, samarium-153, rhenium-186 or rhenium-188) for the treatment of bone metastases
- •Treatment with cytotoxic chemotherapy within 4 weeks prior to registration
- •Symptomatic nodal disease, i.e. scrotal, penile or leg edema. Visceral metastases (including cerebral metastases) from CRPC (>2 lung and/or liver metastases [size ≥2cm]; Lymphadenopathy exceeding 6 cm in short-axis diameter or any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis), as assessed by CT, MRI or chest X-ray within the 8 weeks prior registration.
- •Concurrent chemotherapy. Patients may be on other non-chemotherapy anti-cancer treatments, per FDA labeling of Radium-223, provided that these are not changed during the primary pain assessment period Major surgery within 30 days prior to registration.
- •Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression.
- •Patients with a, "currently active," second malignancy other than non-melanoma skin cancers or non-invasive bladder cancers or other in-situ or non-invasive malignancies. Patients who have completed therapy for a prior malignancy and are free of disease for ≥3 years are eligible.
- •Any other serious illness or medical condition, such as but not limited to:
- •Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
- •Cardiac failure New York Heart Association (NYHA) III or IV
- •Crohn's disease or ulcerative colitis
- •Bone marrow dysplasia
- •Fecal incontinence
- •Any other condition which, in the opinion of the Investigator, would make the subject unsuitable for trial participation
- •NOTE: Any patient found to be ineligible prior to treatment initiation will require re-screening.
研究组 & 干预措施
Radium-223
Experimental
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
干预措施: Radium-223 (Drug)
结局指标
主要结局
Percentage of Participants With 30% Decline in the Brief Pain Inventory (BPI) Worst Pain Item From Baseline to Week 8
时间窗: 8 weeks
Defined as a 30% decline in the Brief Pain Inventory/BPI worse pain item from baseline to week 8, with a confirmed reduction at week 12 without an escalation of the subject's pain regimen from Step 1 to Step 2 or Step 2 to Step 3 of the WHO analgesic ladder.) The baseline BPI worst pain score average will be based on the worst pain scores completed by the participant in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the participant in the 7 day window in order to calculate the average worst pain score. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
次要结局
- Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)(12 weeks)
- Number of Participants With Changes in Other Bone Markers:(1 year)
研究者
研究点 (3)
Loading locations...
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