NCT03692104

Brief Summary

Post implant dosimetry is an essential part of quality assurance after permanent seed prostate brachytherapy. CT imaging is the standard of assessment but due to contouring uncertainties, MR-CT fusion is preferred. This is not always available due to financial restrictions. This study explores the possibility of post implant US-CT fusion to improve contouring accuracy and potentially replace the use of MR-CT fusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

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

November 3, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2018

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

September 27, 2018

Last Update Submit

January 23, 2020

Conditions

Prostate Cancer

Keywords

prostate cancerbrachytherapyQuality assurance

Outcome Measures

Primary Outcomes (1)

  • Comparison of prostate dosimetry assessed by US-CT fusion with respect to the standard MR-CT fusion

    Dosimetry will be calculated using 2 different imaging modalities (US vs MRI) and compared

    1 month

Secondary Outcomes (1)

  • Comparison of prostate volume assessed by 2 different imaging modalities

    1 month

Interventions

transrectal ultrasoundDIAGNOSTIC_TEST

Use of US for post implant quality assessment

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients undergoing prostate brachytherapy for localized prostate cancer.

You may qualify if:

  • localized prostate cancer suitable for permanent seed implant brachytherapy as either monotherapy or as a boost

You may not qualify if:

  • Unable to undergo MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer

Kelowna, British Columbia, V1Y5L3, 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

  • Francois Bachand, MD

    BC Cancer

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiation Oncologist

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 2, 2018

Study Start

November 3, 2017

Primary Completion

February 28, 2018

Study Completion

December 31, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)