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

NCT00551044 | Completed DMC

• 1 other identifier: 96/02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Prostatic Neoplasms

Keywords

prostatic neoplasms; bicalutamide; quality of life; osteoporosis

Outcome Measures

Primary Outcomes (1)

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

  3 monthly for 1 year

Secondary Outcomes (4)

• Renal & liver function tests, PSA, testosterone, estradiol

  3 monthly for 1 year

• Body Mass Index, arm anthropometry (mid-upper arm circumference and triceps skin fold thickness), dynamometry (quadriceps muscle strength)

  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

  3 monthly for 12 months

• Peripheral bone densitometry of non-dominant forearm

  At baseline and 12 months

Study Arms (1)

Bicalutamide

ACTIVE COMPARATOR

Osteoporotic patients (T score ≤ -2.5) on bicalutamide

Drug: Bicalutamide

Interventions

Bicalutamide DRUG

Bicalutamide 150mg once daily, oral administration, for 12 months

Bicalutamide

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wirral University Teaching Hospital NHS Trust: lead
• AstraZeneca: collaborator

Study Sites (1)

Wirral University Teaching Hospitals NHS Trust

Upton, Wirral, Merseyside, CH48 5PE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 20950306 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Osteoporosis

Interventions

bicalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nigel J Parr, MBBS, FRCS(Urol), MD

  Wirral University Teaching Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: August 1, 2003
• Study Completion: August 1, 2005
• Last Updated: October 30, 2007

Record last verified: 2007-08

Locations

GB (1)