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Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
This study has been completed.
Sponsors and Collaborators: Wirral University Teaching Hospital NHS Trust
AstraZeneca
Information provided by: Wirral University Teaching Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00551044
  Purpose

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


Condition Intervention
Prostatic Neoplasms
Drug: Bicalutamide

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Bicalutamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer

Further study details as provided by Wirral University Teaching Hospital NHS Trust:

Primary Outcome Measures:
  • Quality of life (using Rand 36-Item Health Survey SF-36) [ Time Frame: 3 monthly for 1 year ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: August 2003
Study Completion Date: August 2005
Arms Assigned Interventions
Bicalutamide: Active Comparator
Osteoporotic patients (T score ≤ -2.5) on bicalutamide
Drug: Bicalutamide
Bicalutamide 150mg once daily, oral administration, for 12 months

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

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00551044

Locations
United Kingdom, Wirral, Merseyside
Wirral University Teaching Hospitals NHS Trust
Upton, Wirral, Merseyside, United Kingdom, CH48 5PE
Sponsors and Collaborators
Wirral University Teaching Hospital NHS Trust
AstraZeneca
Investigators
Principal Investigator: Nigel J Parr, MBBS, FRCS(Urol), MD Wirral University Teaching Hospital NHS Trust
  More Information

Study ID Numbers: 96/02
Study First Received: October 29, 2007
Last Updated: October 29, 2007
ClinicalTrials.gov Identifier: NCT00551044  
Health Authority: United Kingdom: National Health Service

Keywords provided by Wirral University Teaching Hospital NHS Trust:
prostatic neoplasms
bicalutamide
quality of life
osteoporosis

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Bicalutamide
Quality of Life
Osteoporosis
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:
Androgen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009