NCT00087659已完成不适用
A Prostate Cancer Study in Men Undergoing Androgen Deprivation Therapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 31
- 主要终点
- Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
研究概览
简要总结
This study is being conducted to compare the effect of an investigational drug versus placebo on bone loss in men with prostate cancer who are receiving Androgen Deprivation Therapy (ADT). The study drug or placebo will be administered every three months of four treatments in one year.
In order to participate, male patients 18 years and older must be consecutive veterans from participating Veterans Administration Medical Centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Signed informed consent
- •Age > 18 years
- •Histologically confirmed diagnosis of carcinoma of the prostate
- •No distant metastases at the start of ADT and continuously low PSA (<2.0) on continuous ADT (stage Tany Nany MO).
- •Patients initiating or receiving ADT with a LHRH agonist (with or without an antiandrogen) and with the intended duration of ADT of at least 12 months at the time of randomization. Patients undergoing bilateral orchiectomy or with history of this procedure are also eligible.
- •Patient with a baseline BMD T-score at or above -2.0 standard deviations in the lumbar spine (L2-L4) and the total hip are eligible
- •Life expectancy of at least 12 months
- •Zubrod performance status of 0, 1, or 2
排除标准
- •Patients who received any prior bisphosphonate therapy in the past 6 months
- •Metabolic bone disease including Paget's disease or hyperparathyroidism
- •Radiographic evidence of bone metastases
- •Patients who have received prior treatment with systemic corticosteroids within the past 12 months (short term corticosteroid therapy, e.g. to prevent/treat chemotherapy-induced nausea/vomiting or for acute illness like asthma exacerbation, is acceptable)
- •Patients with prior exposure to anabolic steroids or growth hormone within the past 6 months
- •Current treatment with estrogen or complementary medicines known to contain estrogens
- •Patients with clinical or radiological evidence of existing fracture in the lumbar spine and/or total hip
- •Patients with a history of fracture with low-intensity or no associated trauma
- •Patients with any prior treatment for osteoporosis
- •Patients with previous or concomitant malignancy within the past 5 years except adequately treated basal or squamous cell carcinoma of the skin, and colonic polyps with non-invasive malignancy which have been removed
- •Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol, including:
- •uncontrolled infections
- •uncontrolled type 2 diabetes mellitus
- •diseases with influence on bone metabolism, such as Paget's disease or uncontrolled thyroid or parathyroid dysfunction
- •cardiovascular, renal, hepatic, pulmonary and neurologic/psychiatric diseases which would prevent prolonged follow-up
- •History of surgery at the lumbosacral spine, with or without implantable devices, bilateral hip replacement or bilateral hip surgery with implantation of an appliance
- •Patients treated with systemic investigational drugs(s) and /or device(s) within the past 30 days
- •Patients with abnormal renal function as evidenced by either a serum creatinine greater than 3 mg/dL or by a calculated creatinine clearance of 60 ml/minute or less
- •Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl (2.00 mmol/L)
- •Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study
结局指标
主要结局
Percent change in bone mineral density of the lumbar spine (L2-L4) at 6 and 12 months.
次要结局
- Percent change in bone mineral density of the total hip (including femoral neck, trachanteric region, and Ward's triangle) following one year of therapy.
研究者
研究点 (31)
Loading locations...
相似试验
已完成
2 期
A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer PatientsProstate CancerNCT00466440Eli Lilly and Company108
Unknown
3 期
Androgen Suppression Combined With Elective Nodal and Dose Escalated Radiation TherapyProstate CancerNCT00175396University of British Columbia400
已完成
4 期
A Study of Tadalafil After Radical ProstatectomyErectile DysfunctionNCT01026818Eli Lilly and Company583
终止
2 期
Testosterone Replacement in Men With Non-Metastatic Castrate Resistant Prostate CancerProstate CancerNCT00515112University of Chicago6
已完成
不适用
A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate CancerProstate CancerNCT01084759Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins16