Quality of Life Following Radical Prostatectomy | NCT00373308

Studies
Quality of Life Following Radical Prostatectomy

NCT00373308

Sponsor

Stanford University

Status

Completed

Last Update Posted

Aug 5, 2021Actual

Enrollment

888Actual

Phase

Not provided

Conditions

Prostatic Neoplasms
Prostate Cancer

Interventions

Not provided

Countries

United States

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
78463	Other Identifier	Stanford University Alternate IRB Approval Number
PROS0012	Other Identifier	Stanford University

Status Module

Record Verification Date

Aug 2021

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

Sep 2002

Primary Completion Date

Dec 25, 2020Actual

Completion Date

Dec 25, 2020Actual

First Submitted Date

Sep 6, 2006

First Submission Date that Met QC Criteria

Sep 6, 2006

First Posted Date

Sep 8, 2006Estimated

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

Aug 3, 2021

Last Update Posted Date

Aug 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study will utilize the Expanded Prostate Cancer Index Composite questionnaire to learn what impact the surgery has upon the participant's sense of health, sexual and urinary quality of life.

Detailed Description

To define impact on quality of life issues for patients undergoing radical prostatectomy. This study will distribute a questionnaire to patients who are being scheduled for radical prostatectomy, both before and after surgery, to assess the impact on quality of life issues. This will provide important information regarding the temporal return of issues pertaining to quality of life.

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

888Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
urinary and bowel habits		before and after surgery
sexual and hormonal index as self-reported in the questionnaires		before and after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Patients scheduled to undergo radical prostatectomy at Stanford

Exclusion Criteria:

- Patients treated with neoadjuvant or adjuvant hormonal therapy or radiation therapy

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients scheduled to undergo radical prostatectomy at Stanford

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Benjamin I Chung	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine		Stanford	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided