A Phase I Pilot Study Comparing 123I MIP 1072 Versus 111In Capromab Pendetide in Subjects With Metastatic Prostate Cancer
研究概览
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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California
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Laguna Niguel、California、美国、92677
- West Coast Radiology Centers
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Newport Beach、California、美国、92663
- Pacific Coast Imaging
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San Francisco、California、美国、94143
- University of California - San Francisco
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Maryland
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Baltimore、Maryland、美国、21201
- University of Maryland
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New York
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New York、New York、美国、10065
- New York Presbyterian Hospital - Weill Cornell Medical College
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Texas
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Houston、Texas、美国、77030
- Vanguard Urologic Research Foundation
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Subjects must meet all of the following criteria to be enrolled in this study.
- Male aged 18 years or older
- Signed written informed consent and willingness to comply with protocol requirements
- Histologic diagnosis of prostate cancer by validated history and/or biopsy of the prostate or of a metastatic lesion.
Evidence of metastatic disease as documented by an abnormal bone scan and CT scan or MRI plus:
Castration/anti androgen therapy naïve/sensitive:
- Gleason Score ≥ 7 and PSA ≥ 2.0 ng/mL with history of prostatectomy or primary radiation therapy of the prostate gland and prior undetectable PSA or; PSA > 10.0 ng/mL if intact prostate, or
- Gleason score ≤ 6 and PSA is ≥ 20 ng/mL, or
- Gleason Score ≥ 8 and any doubling of PSA, or PSA > 0.5 ng/mL, or
- Clinical Stage 3 and Gleason Score ≥ 8
If on anti androgen therapy, must have initiated therapy at least 4 weeks prior to treatment.
Castration/anti androgen therapy resistant:
- Patients must have current or historical evidence of disease progression concomitant with surgical (orchiectomy) or medical castration (LHRH analogue); anti androgen withdrawal (4 weeks for flutamide and 6 weeks for nilutamide or bicalutamide) is necessary only for patients on anti androgens who have demonstrated a > 3 month duration of beneficial response to anti androgens; progression is demonstrated by any of the following:
I. PSA progression: 2 serial rising PSA determinations at least 14 days apart over the PSA nadir, with the last measurement ≥ 2 ng/mL
II. Progression of measurable disease, or progression of non measurable disease as defined by:
i. Soft tissue disease: The appearance of one or more new lesions, and/or unequivocal worsening of non measurable disease when compared to imaging studies acquired during castration therapy or against the precastration studies if there was no response, or ii. Bone disease: Appearance of two or more new areas of abnormal uptake on bone scan when compared to imaging studies acquired during castration therapy or against the pre castration studies if there was no response.
III. Increased uptake of pre existing lesions on bone scan does not constitute progression.
IV. Testosterone ≤ 50 ng/dL achieved via medical or surgical castration.
- Male subjects who are fertile agree to use an acceptable form of birth control, defined as abstinence, barrier or other acceptable, effective contraceptive method throughout the study period. A second form of barrier birth control must be utilized if a subject's partner is using oral contraception until at least seven days after the last injection.
- Karnofsky performance is ≥ 50
Adequate hematologic, renal and liver function:
- WBC ≥ 2.0×103/mm3 (ANC > 1.0 x 103 mm3)
- Platelet count ≥ 75×103/mm3
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 2.5 mg/dL
- Total bilirubin ≤ 2x ULN
- AST, ALT ≤ 5x ULN
Exclusion Criteria:
- Karnofsky performance status of < 50
- Subject has received a permanent prostate brachytherapy implant within the last 3 months for 103Pd implants or 12 months for 125I implants
- Subject was administered a diagnostic radioisotope within 5 physical half lives of that radioisotope prior to study enrollment
- Subject has received an investigational compound and/or medical device or has been part of an investigational study within the past 30 days before enrollment into this study
- Any treatment with radiopharmaceuticals, e.g. Strontium 89 and Samarium 153 within 6 months prior to enrollment
- Ketoconazole or anti androgens (flutamide, nilutamide, bicalutamide) within 4 weeks prior to enrollment. Patients who demonstrate an antiandrogen withdrawal response, defined as a > 25% drop in PSA within 4 weeks (flutamide) or 6 weeks (nilutamide, bicalutamide) of stopping a non steroidal anti androgen, are not eligible until the PSA rises above the nadir observed after anti androgen withdrawal
- Initiation of bisphosphonate therapy within 28 days prior to enrollment. Patients taking bisphosphonates should not have their dosing regimen altered unless medically warranted in the interval between baseline scans and end of study
- Subject has any medical condition or other circumstances which, in the opinion of the Investigator, would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow up examinations
- Subject is determined by the Investigator to be clinically unsuitable for the study
- If the subject has had any other malignancies within the past year, other than basal or squamous cell carcinoma of the skin, diagnosis and location must be defined or be defined as clinically controlled or treated to complete response
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:非随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Previous ProstaScint®
Subjects with a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 alone.
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Single 10 mCi intravenous injection
其他名称:
Single 5 mCi intravenous injection
其他名称:
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实验性的:No Previous ProstaScint®
Subjects without a previous 111-In capromab pendetide image of sufficient quality obtained within 60 days of study enrollment will receive 123-I-MIP-1072 and 111-In capromab pendetide imaging.
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Single 10 mCi intravenous injection
其他名称:
Single 5 mCi intravenous injection
其他名称:
Single 5 mCi intravenous injection
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Estimate the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide in subjects with metastatic prostate cancer by determining the presence and extent of the disease.
大体时间:24 hours post-injection
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24 hours post-injection
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次要结果测量
结果测量 |
大体时间 |
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Examine the imaging sensitivity and specificity of 10.0 mCi or 5.0 mCi of 123I MIP 1072 compared to 5 mCi of 111In capromab pendetide on a per lesion basis in subjects with metastatic prostate cancer
大体时间:Through 2 weeks post-injection
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Through 2 weeks post-injection
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To describe the safety of administering 10.0 mCi and 5.0 mCi of 123I MIP 1072 for the detection of metastatic prostate cancer
大体时间:Through 2 weeks post-injection
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Through 2 weeks post-injection
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合作者和调查者
调查人员
- 首席研究员:Mack Roach, MD、University of California, San Francisco
- 首席研究员:Jeffrey Dobkin, MD、Pacific Coast Imaging
- 首席研究员:Stanley Goldsmith, MD、NY Presbyterian Hospital - Weill Cornell Medical Center
- 首席研究员:Edward Coleman, MD、Duke University
- 首席研究员:Arif Hussain, MD、University of Maryland
- 首席研究员:Kevin Slawin, MD、Vanguard Urologic Research Foundation
- 首席研究员:Samuel L Kipper, MD、West Coast Radiology Centerse
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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123-I-MIP-1072的临床试验
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