Clinical trial NCT00551044: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: prostatic neoplasms
bicalutamide
quality of life
osteoporosis
Lead sponsor: Wirral University Teaching Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-10-30
Enrollment: 42
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life (using Rand 36-Item Health Survey SF-36)
timeFrame: 3 monthly for 1 year
Secondary outcomes:
measure: Renal & liver function tests, PSA, testosterone, estradiol
timeFrame: 3 monthly for 1 year
measure: Body Mass Index, arm anthropometry (mid-upper arm circumference and triceps skin fold thickness), dynamometry (quadriceps muscle strength)
timeFrame: 3 monthly for 1 year
measure: 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
timeFrame: 3 monthly for 12 months
measure: Peripheral bone densitometry of non-dominant forearm
timeFrame: At baseline and 12 months
Other outcomes:
Locations:
city: Upton
country: United Kingdom
facility: Wirral University Teaching Hospitals NHS Trust
state: Wirral, Merseyside
Study officials:
affiliation: Wirral University Teaching Hospital NHS Trust
name: Nigel J Parr, MBBS, FRCS(Urol), MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wadhwa VK, Weston R, Parr NJ. Bicalutamide monotherapy preserves bone mineral density, muscle strength and has significant health-related quality of life benefits for osteoporotic men with prostate cancer. BJU Int. 2011 Jun;107(12):1923-9. doi: 10.1111/j.1464-410X.2010.09726.x. Epub 2010 Oct 15.