A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer

NCT ID: NCT00777452

Last Updated: 2008-10-22

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

Total Enrollment

93 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-12-31

Brief Summary

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to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer.

Detailed Description

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Quality of life is of great concern to patients considering treatment options for prostate cancer. Patients with clinically localized prostate cancer treated with active surveillance, radical prostatectomy, external radiotherapy and high intensity focused ultrasound were included. All men completed the questionnaires of Functional Assessment of Cancer Therapy-Prostate (FACT-P) (version 4), International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF) before treatment and 1, 3, 6, 12 months after treatment.

Conditions

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Prostate Cancer

Keywords

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quality of life localized prostate cancer FACT-P

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

active surveillance

No interventions assigned to this group

2

radical prostatectomy

No interventions assigned to this group

3

external beam radiotherapy

No interventions assigned to this group

4

high intensity focused ultrasound

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with clinically localized prostate cancer

Exclusion Criteria

* patients with another malignancies
Minimum Eligible Age

43 Years

Maximum Eligible Age

82 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Samsung Medical Center,Sungkyunkwan University School of Medicine

Principal Investigators

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Han Yong Choi, professor

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Locations

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Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Hashine K, Kusuhara Y, Miura N, Shirato A, Sumiyoshi Y, Kataoka M. A prospective longitudinal study comparing a radical retropubic prostatectomy and permanent prostate brachytherapy regarding the health-related quality of life for localized prostate cancer. Jpn J Clin Oncol. 2008 Jul;38(7):480-5. doi: 10.1093/jjco/hyn059. Epub 2008 Jul 11.

Reference Type RESULT
PMID: 18621847 (View on PubMed)

Namiki S, Satoh T, Baba S, Ishiyama H, Hayakawa K, Saito S, Arai Y. Quality of life after brachytherapy or radical prostatectomy for localized prostate cancer: a prospective longitudinal study. Urology. 2006 Dec;68(6):1230-6. doi: 10.1016/j.urology.2006.08.1093. Epub 2006 Dec 4.

Reference Type RESULT
PMID: 17141839 (View on PubMed)

Jo Y, Junichi H, Tomohiro F, Yoshinari I, Masato F. Radical prostatectomy versus high-dose rate brachytherapy for prostate cancer: effects on health-related quality of life. BJU Int. 2005 Jul;96(1):43-7. doi: 10.1111/j.1464-410X.2005.05564.x.

Reference Type RESULT
PMID: 15963118 (View on PubMed)

Other Identifiers

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CRS104-10-4

Identifier Type: -

Identifier Source: secondary_id

SMC IRB 2004-05-21

Identifier Type: -

Identifier Source: org_study_id