Bicalutamide Monotherapy Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
October 29, 2007 updated by: Wirral University Teaching Hospital NHS Trust
Bicalutamide Monotherapy Preserves Bone Mineral Density, Muscle Strength and Has Significant Quality of Life Benefits for Men With Advanced Prostate Cancer
The aim of this study is to comprehensively monitor the effects of a nonsteroidal antiandrogen in patients requiring hormone manipulation for prostate cancer
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wirral, Merseyside
-
Upton, Wirral, Merseyside, United Kingdom, CH48 5PE
- Wirral University Teaching Hospitals NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Bicalutamide
Osteoporotic patients (T score ≤ -2.5) on bicalutamide
|
Bicalutamide 150mg once daily, oral administration, for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life (using Rand 36-Item Health Survey SF-36)
Time Frame: 3 monthly for 1 year
|
3 monthly for 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Renal & liver function tests, PSA, testosterone, estradiol
Time Frame: 3 monthly for 1 year
|
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
|
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
|
3 monthly for 12 months
|
|
Peripheral bone densitometry of non-dominant forearm
Time Frame: At baseline and 12 months
|
At baseline and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Nigel J Parr, MBBS, FRCS(Urol), MD, Wirral University Teaching Hospital NHS Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2003
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
October 29, 2007
First Submitted That Met QC Criteria
October 29, 2007
First Posted (Estimate)
October 30, 2007
Study Record Updates
Last Update Posted (Estimate)
October 30, 2007
Last Update Submitted That Met QC Criteria
October 29, 2007
Last Verified
August 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 96/02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.