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临床试验/NCT00551044
NCT00551044已完成不适用

Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer

Wirral University Teaching Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2003年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Quality of life (using Rand 36-Item Health Survey SF-36)

研究概览

简要总结

The aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for prostate cancer

详细描述

Androgen deprivation therapy is the mainstay of treatment for advanced prostate cancer. There is an increasing tendency towards earlier treatment with hormone manipulation. However, luteinizing hormone-releasing agonists decrease serum testosterone to castrate levels within two weeks of commencement.They are associated with loss of libido, loss of muscle bulk and accelerated bone loss. Osteoporotic patients are at high risk of fragility fractures. An alternative is the nonsteroidal antiandrogen bicalutamide which blocks testosterone at the receptor level, allowing androgen deprivation in the prostate without reducing circulating levels of testosterone. This should preserve the desired effects on other androgen-sensitive tissue, resulting in an advantageous side effect profile. The aim of our study is to closely monitor osteoporotic patients commencing bicalutamide for a period of 12 months. Patients will be reviewed in a dedicated prostate cancer clinic every 3 months. Patients will be questioned regarding adverse events. Renal and liver function tests, prostate specific antigen, testosterone, estradiol and bone turnover markers will be measured 3 monthly. Measurement of height , weight, body mass index, quadriceps strength using dynamometry, and skeletal mass using arm anthropometry (mid-arm circumference and triceps skinfold thickness), will be carried out 3 monthly. Quality of life issues will be assessed 3 monthly using the Rand 36-Item Health Survey (SF36) and University of California-Los Angeles Prostate Cancer Index (UCLAPCI). Patients will undergo bone densitometry of the forearm at baseline and 12 months.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
Male
接受健康志愿者

入选标准

  • Osteoporotic patients (T score ≤ -2.5) with advanced prostate cancer requiring hormone manipulation, due to biochemical relapse following either radical prostatectomy, radiotherapy, brachytherapy, or biochemical progression after initially being observed with prostate cancer.

排除标准

  • Severe hepatic insufficiency, with bilirubin above reference range
  • Previous systemic therapy for prostate cancer
  • Radiotherapy within 6 months
  • Previous other invasive malignancies
  • Any severe concomitant disease.

研究组 & 干预措施

Bicalutamide

Active Comparator

Osteoporotic patients (T score ≤ -2.5) on bicalutamide

干预措施: Bicalutamide (Drug)

结局指标

主要结局

Quality of life (using Rand 36-Item Health Survey SF-36)

时间窗: 3 monthly for 1 year

次要结局

  • Renal & liver function tests, PSA, testosterone, estradiol(3 monthly for 1 year)
  • Body Mass Index, arm anthropometry (mid-upper arm circumference and triceps skin fold thickness), dynamometry (quadriceps muscle strength)(3 monthly for 1 year)
  • Bone turnover markers (bone-specific alkaline phosphatase, N-terminal propeptide of type I collagen, C-telopeptide crosslinks of type I collagen, urine N-telopeptide of tyoe I collagen corrected for creatinine(3 monthly for 12 months)
  • Peripheral bone densitometry of non-dominant forearm(At baseline and 12 months)

研究者

发起方
Wirral University Teaching Hospital NHS Trust
申办方类型
Other

研究点 (1)

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