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

Not Enrolling
Prostatic Neoplasms

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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.

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

3 monthly for 1 year

Principal Investigator

Nigel J Parr, MBBS, FRCS(Urol), MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wirral University Teaching Hospital NHS Trust


United Kingdom: National Health Service

Study ID:




Start Date:

August 2003

Completion Date:

August 2005

Related Keywords:

  • Prostatic Neoplasms
  • prostatic neoplasms
  • bicalutamide
  • quality of life
  • osteoporosis
  • Neoplasms
  • Prostatic Neoplasms