Prostatectomy Prospective Database | NCT00447616

Studies
Prostatectomy Prospective Database

NCT00447616

Sponsor

Kenneth Peters, MD

Status

Terminated

Last Update Posted

Dec 26, 2017Actual

Enrollment

896Actual

Phase

Not provided

Conditions

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

Status Module

Record Verification Date

Dec 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding

Expanded Access Info

Start Date

Oct 2003

Primary Completion Date

Apr 7, 2015Actual

Completion Date

Apr 7, 2015Actual

First Submitted Date

Mar 13, 2007

First Submission Date that Met QC Criteria

Mar 13, 2007

First Posted Date

Mar 15, 2007Estimated

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

Dec 21, 2017

Last Update Posted Date

Dec 26, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health.

Detailed Description

The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. Participation in the study will allow collection of medical information related to prostate cancer treatment from hospital and doctor's office records. Questionnaires will be completed reflecting bladder, bowel, and sexual function, and quality of life at three, six, twelve, eighteen, and twenty-four months after surgery, and yearly thereafter.

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

896Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

males greater than 18 years of age
patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.

Exclusion Criteria:

dementia

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 having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth M Peters, M.D.	Corewell Health East	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
William Beaumont Hospital		Royal Oak	Michigan	48073	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