NCT01437085

Brief Summary

Prostate brachytherapy is an effective treatment option for men with localized prostate cancer, with excellent cure rates and a favorable toxicity profile. With the current needle insertion technique, seed placement inaccuracy is primarily caused by needle deflection and soft tissue deformation, which both occur during the brachytherapy operation. This study will accrue 20 patients undergoing prostate brachytherapy implants and acquire a series of ultrasound images, video clips and one CT scan.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

5.8 years

First QC Date

September 19, 2011

Last Update Submit

January 23, 2017

Conditions

Prostate Cancer

Keywords

Needle deflectionProstate DeformationProstate BrachytherapyNeedles

Eligibility Criteria

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

Patients having a prostate brachytherapy implant at the Cross Cancer Institute.

You may qualify if:

  • Prostate cancer
  • Treated with prostate brachytherapy at the Cross Cancer Institute
  • Low and intermediate risk prostate cancer
  • ambulatory patients
  • stable medical condition
  • Over 18 years of age
  • Capable of giving informed consent

You may not qualify if:

  • Any hormonal therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, 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

  • Nawaid Usmani, MD, FRCPC

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 20, 2011

Study Start

October 1, 2011

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

CA(1)