Clinical trial NCT00777452: A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer
Official title: A Prospective Quality of Life Study in Men With Clinically Localized Prostate Carcinoma Treated With Different Treatment Modalities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: quality of life
localized prostate cancer
FACT-P
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2008-10-22
Enrollment: 93
Sex: MALE
Minimum age (years): 43
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with clinically localized prostate cancer at single tertiary institution

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with clinically localized prostate cancer

Exclusion Criteria:

* patients with another malignancies

Primary outcomes:
measure: Health-related quality of life changes over time
timeFrame: 12 months after treatment
Secondary outcomes:
measure: urinary symptom score and erectile function over time
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Han Yong Choi, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.