NCT00923416

Brief Summary

The goal of this study is to identify any side effects caused by the implanting of markers via the rectum. The investigators will also try to determine if any other factors (such as the position of the markers) influence the risk of side effects. The study procedures consist of two questionnaires:The first will be completed immediately after the marker implantation and the second questionnaire will be completed during your radiotherapy planning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2008

Typical duration 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

September 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

2.2 years

First QC Date

June 16, 2009

Last Update Submit

December 18, 2012

Conditions

Prostate Cancer

Keywords

Intra-Prostate MarkersTransrectal UltrasoundProstate Cancer Patients

Outcome Measures

Primary Outcomes (1)

  • Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT

    1.5 years

Study Arms (1)

Prostate Cancer

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Prostate Cancer Patients who has trans-rectal ultrasound-guided implantation of intra-prostatic markers for radiotherapy treatment

You may qualify if:

  • Have biopsy confirmed prostate cancer (any risk category)
  • Have 3 intra-prostatic markers inserted at PMH prior to radiotherapy
  • Be willing to provide written informed consent
  • Be willing to complete the adverse event questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tara Rosewall

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2009

First Posted

June 18, 2009

Study Start

September 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

CA(1)