Quality of Life After Permanent Interstitial Iodine Seed... | NCT02652000

Studies
Quality of Life After Permanent Interstitial Iodine Seed Prostate Brachytherapy

NCT02652000

Sponsor

Kantonsspital Graubuenden

Status

Completed

Last Update Posted

Dec 13, 2016Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Neoplasms, Prostate

Interventions

No intervention in this retrospective study

Countries

Switzerland

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 2016

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

Oct 2009

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Jan 6, 2016

First Submission Date that Met QC Criteria

Jan 7, 2016

First Posted Date

Jan 11, 2016Estimated

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 11, 2016

Last Update Posted Date

Dec 13, 2016Estimated

Name	Class
University of Zurich	OTHER

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

Retrospective study to analyze Quality of life in men after iodine seed brachytherapy for localized prostate cancer

Detailed Description

Retrospective Evaluation of Quality of life data collected on men who underwent iodine seed brachytherapy at the University Hospital Zurich

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

50Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention in this retrospective study	Other	No Intervention in this retrospective Analysis.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CTCAE v4.03ff Grade 1-4 Sexual/Reproductive Function	Scale	5 years (2009-2014)

Secondary Outcomes

Measure	Description	Time Frame
CTCAE v4.03ff Grade 1-4 Gastrointestinal	Scale	5 years (2009-2014)
CTCAE v4.03ff Grade 1-4 Renal/Genitourinary	Scale	5 years (2009-2014)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male > 18 years of age
iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich

Exclusion Criteria:

No iodine seed brachytherapy for localized prostate cancer at the University Hospital Zurich

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

48 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients having had idodine seed brachytherapy for localized prostate cancer between 2009 and 2014

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel R Zwahlen, MD, MBA	Kantonsspital Graubuenden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Graubuenden, Department of Radiaton Oncology		Chur		7000	Switzerland

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