Prostate CancerNCT00777452
A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer
An observational study of Prostate Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer. Read more about this study
- Who is it for?
- Ages 43 to 82 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 93 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 43 to 82 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: patients with clinically localized prostate cancer at single tertiary institution
Who may be able to join
- patients diagnosed with clinically localized prostate cancer
Who cannot join
- patients with another malignancies
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
Official title: A Prospective Quality of Life Study in Men With Clinically Localized Prostate Carcinoma Treated With Different Treatment Modalities
to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer.
Read the 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.
- Conditions
- Prostate Cancer
- Keywords
- quality of life, localized prostate cancer, FACT-P
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | active surveillance | |
| 2 | radical prostatectomy | |
| 3 | external beam radiotherapy | |
| 4 | high intensity focused ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life changes over time
Measured: 12 months after treatment
Secondary outcomes (1)
urinary symptom score and erectile function over time
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startMar 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Han Yong Choi, professor, Principal investigator, Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777452
- Sponsor's protocol ID
- SMC IRB 2004-05-21
- Other IDs
- CRS104-10-4
- Status last verified
- Oct 2008
- First submitted
- 21 Oct 2008
- Last updated
- 22 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18621847Namiki 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.
PubMed 17141839Jo 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.
PubMed 15963118
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Quality of Life Study in Men With Clinically Localized Prostate Carcinoma Treated With Different Treatment Modalities
- ClinicalTrials.gov ID
- NCT00777452
- Acronym / sponsor ID
- SMC IRB 2004-05-21
- Conditions
- Prostate Cancer
- Keywords
- quality of life, localized prostate cancer, FACT-P
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –active surveillance |
| 2 | – | –radical prostatectomy |
| 3 | – | –external beam radiotherapy |
| 4 | – | –high intensity focused ultrasound |
Who may qualify
- Ages
- 43 to 82 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with clinically localized prostate cancer at single tertiary institution
Key inclusion criteria (1 listed)
- patients diagnosed with clinically localized prostate cancer
Key exclusion criteria (1 listed)
- patients with another malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health-related quality of life changes over time
Time frame: 12 months after treatment
1 secondary outcome
urinary symptom score and erectile function over time
Time frame: 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2008.
- Results publication: PubMed 18621847Hashine 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.
- Results publication: PubMed 17141839Namiki 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.
- Results publication: PubMed 15963118Jo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Han Yong Choi, professor principal investigator
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life changes over time (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00777452, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2008.