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Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
This study has been completed.
Study NCT00551044   Information provided by Wirral University Teaching Hospital NHS Trust
First Received: October 29, 2007   No Changes Posted
This Tabular View shows the required WHO registration data elements as marked by

October 29, 2007
October 29, 2007
August 2003
Quality of life (using Rand 36-Item Health Survey SF-36) [ Time Frame: 3 monthly for 1 year ]
Same as current
No Changes Posted
  • Renal & liver function tests, PSA, testosterone, estradiol [ Time Frame: 3 monthly for 1 year ]
  • Body Mass Index, arm anthropometry (mid-upper arm circumference and triceps skin fold thickness), dynamometry (quadriceps muscle strength) [ Time Frame: 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 [ Time Frame: 3 monthly for 12 months ]
  • Peripheral bone densitometry of non-dominant forearm [ Time Frame: At baseline and 12 months ]
Same as current
 
Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer

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

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.

 
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Prostatic Neoplasms
Drug: Bicalutamide
Active Comparator: Osteoporotic patients (T score ≤ -2.5) on bicalutamide
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
42
August 2005
 

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Male
 
No
 
United Kingdom
 
 
NCT00551044
 
 
Wirral University Teaching Hospital NHS Trust
AstraZeneca
Principal Investigator: Nigel J Parr, MBBS, FRCS(Urol), MD Wirral University Teaching Hospital NHS Trust
Wirral University Teaching Hospital NHS Trust
August 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.