NCT02652000

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 13, 2016

Status Verified

December 1, 2016

Enrollment Period

7.2 years

First QC Date

January 6, 2016

Last Update Submit

December 11, 2016

Conditions

Neoplasms, Prostate

Outcome Measures

Primary Outcomes (1)

  • CTCAE v4.03ff Grade 1-4 Sexual/Reproductive Function

    Scale

    5 years (2009-2014)

Secondary Outcomes (4)

  • CTCAE v4.03ff Grade 1-4 Gastrointestinal

    5 years (2009-2014)

  • CTCAE v4.03ff Grade 1-4 Renal/Genitourinary

    5 years (2009-2014)

  • International Prostate Symptom Score (IPSS)

    5 years (2009-2014)

  • International Index of erectile function, five items (IIEF-5)

    5 years (2009-2014)

Interventions

No intervention in this retrospective studyOTHER

No Intervention in this retrospective Analysis.

Eligibility Criteria

Age48 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Graubuenden, Department of Radiaton Oncology

Chur, 7000, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Daniel R Zwahlen, MD, MBA

    Kantonsspital Graubuenden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MBA

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 11, 2016

Study Start

October 1, 2009

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 13, 2016

Record last verified: 2016-12

Locations

CH(1)