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Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00551044
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : October 30, 2007
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Wirral University Teaching Hospital NHS Trust

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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Bicalutamide Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
Study Start Date : August 2003
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Active Comparator: Bicalutamide
Osteoporotic patients (T score ≤ -2.5) on bicalutamide
Drug: Bicalutamide
Bicalutamide 150mg once daily, oral administration, for 12 months




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

Secondary Outcome Measures :
  1. Renal & liver function tests, PSA, testosterone, estradiol [ Time Frame: 3 monthly for 1 year ]
  2. 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 ]
  3. 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 ]
  4. Peripheral bone densitometry of non-dominant forearm [ Time Frame: At baseline and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00551044


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00551044    
Other Study ID Numbers: 96/02
First Posted: October 30, 2007    Key Record Dates
Last Update Posted: October 30, 2007
Last Verified: August 2007
Keywords provided by Wirral University Teaching Hospital NHS Trust:
prostatic neoplasms
bicalutamide
quality of life
osteoporosis
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents