A Prospective Longitudinal Study of Health-Related Qualit... | NCT00777452

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

NCT00777452

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Oct 22, 2008Estimated

Enrollment

93Actual

Phase

Not provided

Conditions

Prostate Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
CRS104-10-4

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Oct 21, 2008

First Submission Date that Met QC Criteria

Oct 21, 2008

First Posted Date

Oct 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2008

Last Update Posted Date

Oct 22, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		active surveillance
2		radical prostatectomy
3		external beam radiotherapy
4		high intensity focused ultrasound

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health-related quality of life changes over time		12 months after treatment

Secondary Outcomes

Measure	Description	Time Frame
urinary symptom score and erectile function over time		12 months after treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients diagnosed with clinically localized prostate cancer

Exclusion Criteria:

patients with another malignancies

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

43 Years

Maximum Age

82 Years

Standard Ages

AdultOlder Adult

Study Population

patients with clinically localized prostate cancer at single tertiary institution

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Han Yong Choi, professor	Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine		Seoul		135-710	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18621847	Result	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.
17141839

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms