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

NCT ID: NCT00551044

Last Updated: 2007-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-08-31

Brief Summary

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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

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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.

Conditions

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Prostatic Neoplasms

Keywords

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prostatic neoplasms bicalutamide quality of life osteoporosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bicalutamide

Osteoporotic patients (T score ≤ -2.5) on bicalutamide

Group Type ACTIVE_COMPARATOR

Bicalutamide

Intervention Type DRUG

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

Interventions

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Bicalutamide

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

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Wirral University Teaching Hospital NHS Trust

OTHER

Sponsor Role lead

Principal Investigators

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Nigel J Parr, MBBS, FRCS(Urol), MD

Role: PRINCIPAL_INVESTIGATOR

Wirral University Teaching Hospital NHS Trust

Locations

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Wirral University Teaching Hospitals NHS Trust

Upton, Wirral, Merseyside, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 20950306 (View on PubMed)

Other Identifiers

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96/02

Identifier Type: -

Identifier Source: org_study_id