Trial Information

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