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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Bicalutamide
Sponsored by
Wirral University Teaching Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring prostatic neoplasms, bicalutamide, quality of life, osteoporosis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Wirral University Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Bicalutamide

Arm Description

Osteoporotic patients (T score ≤ -2.5) on bicalutamide

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Renal & liver function tests, PSA, testosterone, estradiol
Body Mass Index, arm anthropometry (mid-upper arm circumference and triceps skin fold thickness), dynamometry (quadriceps muscle strength)
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
Peripheral bone densitometry of non-dominant forearm

Full Information

First Posted
October 29, 2007
Last Updated
October 29, 2007
Sponsor
Wirral University Teaching Hospital NHS Trust
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00551044
Brief Title
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

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wirral University Teaching Hospital NHS Trust
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
prostatic neoplasms, bicalutamide, quality of life, osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bicalutamide
Arm Type
Active Comparator
Arm Description
Osteoporotic patients (T score ≤ -2.5) on bicalutamide
Intervention Type
Drug
Intervention Name(s)
Bicalutamide
Intervention Description
Bicalutamide 150mg once daily, oral administration, for 12 months
Primary Outcome Measure Information:
Title
Quality of life (using Rand 36-Item Health Survey SF-36)
Time Frame
3 monthly for 1 year
Secondary Outcome Measure Information:
Title
Renal & liver function tests, PSA, testosterone, estradiol
Time Frame
3 monthly for 1 year
Title
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
Title
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
Title
Peripheral bone densitometry of non-dominant forearm
Time Frame
At baseline and 12 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel J Parr, MBBS, FRCS(Urol), MD
Organizational Affiliation
Wirral University Teaching Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wirral University Teaching Hospitals NHS Trust
City
Upton
State/Province
Wirral, Merseyside
ZIP/Postal Code
CH48 5PE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20950306
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.
Results Reference
derived

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

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