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Tracking Information | |||||
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First Received Date † | October 29, 2007 | ||||
Last Updated Date | October 29, 2007 | ||||
Start Date † | August 2003 | ||||
Current Primary Outcome Measures † |
Quality of life (using Rand 36-Item Health Survey SF-36) [ Time Frame: 3 monthly for 1 year ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer | ||||
Official Title † | Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer | ||||
Brief Summary | The aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for prostate cancer |
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Detailed Description | 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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Prostatic Neoplasms | ||||
Intervention † | Drug: Bicalutamide | ||||
Study Arms / Comparison Groups | Active Comparator: Osteoporotic patients (T score ≤ -2.5) on bicalutamide | ||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 42 | ||||
Completion Date | August 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00551044 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Wirral University Teaching Hospital NHS Trust | ||||
Collaborators †† | AstraZeneca | ||||
Investigators † |
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Information Provided By | Wirral University Teaching Hospital NHS Trust | ||||
Verification Date | August 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |