Phase IV Study to Evaluate Bone Mineral Density in No-bone Metastatic Prostate Cancer Treated With Degarelix (BLADE)
A Pilot Phase IV Study to Evaluate Variation in Bone Mineral Density, Lean and Fat Body Mass Index Measured by Dual-energy X-ray Absorptiometry in Patients With Prostate Cancer Without Bone Metastasis Treated With Degarelix
研究概览
详细说明
Gonadotropin-releasing hormone (GnRH) agonists decrease bone mineral density (BMD) and increase fracture risk in men with prostate carcinoma. GnRH agonists also increase fat mass and decrease lean body mass. These treatment-related changes in body composition may contribute to fatigue, emotional distress, and decreased quality of life. Whereas the consequences of initial GnRH agonist on BMD and body composition are well characterized, less is known regarding the effects of GnRH antagonists. At the best of our knowledge the changes in body composition induced by Degarelix in prostate cancer patients has never been explored. Dual-energy X-ray absorptiometry (DXA) is a reliable and accurate method to determine the changes in body composition in patients with prostate cancer (PCa) undergoing androgen deprivation therapy (ADT).
The change in body composition is a major determinant of increased morbidity and mortality induced by ADT and DXA provides the most precise measure of body composition. This study is designed to obtain explorative information on changes in bone mineral density, fat body mass and lean body mass by DXA scan after administration of Degarelix. These preliminary data compared with historical data of patients submitted to GnRH agonists could provide a rationale for a subsequent prospective randomized clinical trial.
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Brescia、意大利、25123
- 招聘中
- Clinical Department of Urology, university Hospital Spedali Civili di Brescia
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接触：
- Alessandro Antonelli, MD
- 电话号码：+39 030 3995215
- 邮箱：alessandro_antonelli@me.com
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接触：
- Carlotta Palumbo, MD
- 电话号码：+39 030 3995215
- 邮箱：palumbo.carlotta@gmail.com
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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
Inclusion Criteria:
- male outpatients, aged 18 or older, willing and able to provide written informed consent;
- histological diagnosis of prostate carcinoma;
- more than 6-month survival prospect;
- no bone metastases as assessed by bone scintigraphy;
- eligibility to ADT with Degarelix in the opinion of the clinical investigator.
Exclusion Criteria:
- patients with absolute or relative contraindication for prescription of Degarelix. In particular:
- hypersensitivity towards any component of Firmagon®
- patients who receive concomitant medications that might prolong the QT interval, in particular class I A (such as quinidine, procainamide, disopyramide,) or class III antiarrhythmics (such as amiodarone, sotalol, dofetilide, ibutilide)
- patients with history of or risk factors for Torsades de Pointes
- patients who take either methadone or moxifloxacin or antipsychotic
- patients with alteration in electrolyte blood levels (such as sodium, potassium, calcium and magnesium)
- patients with severe kidney and/or liver dysfunctions;
- concomitant bone metabolic disease, such as Paget's disease, primary hyperparathyroidism or chronic hypercortisolism, as recorded by medical history;
- renal failure (baseline serum creatinine more than 1.5 mg/dl);
- prior hormonal treatment;
- prior or concomitant treatment with bisphosphonates or other drugs known to affect bone metabolism (for example steroids, calcitonin);
- patients participating in an interventional clinical trial in which any treatment or follow-up is mandated;
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 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：地加瑞克
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Degarelix (Firmagon®) will be administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule:
Treatment will be continued till clinically indicated or till disease progression. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Changes in fat body mass
大体时间：12 months
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To determine changes in fat body mass after 12 months Degarelix administration.
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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changes in bone mineral density
大体时间：12 months
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to assess changes in bone mineral density after 12 months of therapy;
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12 months
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changes in lean body mass
大体时间：12 months
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to assess changes in lean body mass after 12 months of therapy;
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12 months
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changes in fasting serum lipids
大体时间：12 months
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to assess changes in fasting serum lipids after 12 months of therapy;
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12 months
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changes in bone turn-over markers
大体时间：12 months
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to assess changes in bone turn-over markers after 12 months of therapy;
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12 months
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changes in insulin sensitivity
大体时间：12 months
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to assess changes in insulin sensitivity after 12 months of therapy;
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12 months
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changes in serum follicle stimulating hormone (FSH) levels
大体时间：12 months
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to assess changes in serum FSH levels after 12 months of therapy;
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12 months
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合作者和调查者
出版物和有用的链接
一般刊物
- Smith MR, Lee H, Nathan DM. Insulin sensitivity during combined androgen blockade for prostate cancer. J Clin Endocrinol Metab. 2006 Apr;91(4):1305-8. doi: 10.1210/jc.2005-2507. Epub 2006 Jan 24.
- Smith MR, Finkelstein JS, McGovern FJ, Zietman AL, Fallon MA, Schoenfeld DA, Kantoff PW. Changes in body composition during androgen deprivation therapy for prostate cancer. J Clin Endocrinol Metab. 2002 Feb;87(2):599-603. doi: 10.1210/jcem.87.2.8299.
- Smith MR. Changes in fat and lean body mass during androgen-deprivation therapy for prostate cancer. Urology. 2004 Apr;63(4):742-5. doi: 10.1016/j.urology.2003.10.063.
- Eri LM, Urdal P, Bechensteen AG. Effects of the luteinizing hormone-releasing hormone agonist leuprolide on lipoproteins, fibrinogen and plasminogen activator inhibitor in patients with benign prostatic hyperplasia. J Urol. 1995 Jul;154(1):100-4.
- Smith MR. Osteoporosis and other adverse body composition changes during androgen deprivation therapy for prostate cancer. Cancer Metastasis Rev. 2002;21(2):159-66. doi: 10.1023/a:1020840311573.
- Berruti A, Dogliotti L, Terrone C, Cerutti S, Isaia G, Tarabuzzi R, Reimondo G, Mari M, Ardissone P, De Luca S, Fasolis G, Fontana D, Rossetti SR, Angeli A; Gruppo Onco Urologico Piemontese (G.O.U.P.), Rete Oncologica Piemontese. Changes in bone mineral density, lean body mass and fat content as measured by dual energy x-ray absorptiometry in patients with prostate cancer without apparent bone metastases given androgen deprivation therapy. J Urol. 2002 Jun;167(6):2361-7; discussion 2367.
- Buttigliero C, Vana F, Bertaglia V, Vignani F, Fiori C, Osella G, Porpiglia F, Tucci M, Scagliotti GV, Berruti A. The fat body mass increase after adjuvant androgen deprivation therapy is predictive of prostate cancer outcome. Endocrine. 2015 Sep;50(1):223-30. doi: 10.1007/s12020-015-0525-x. Epub 2015 Jan 15.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
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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Degarelix的临床试验
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NRG OncologyNational Cancer Institute (NCI)主动，不招人