NCT03861507

Brief Summary

This study involves patients who are scheduled for standard care brachytherapy of focal tumours within the prostate, which is normally performed under standard 2-dimensional (2D) ultrasound guidance. The purpose of this study is the acquire power Doppler ultrasound while using a simple oscillator in physical contact with the end of a brachytherapy needle. The vibrations along the needle should be visible in the power Doppler ultrasound, helping to visualize the needle position within the anatomy.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 28, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

March 4, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

5.4 years

First QC Date

February 28, 2019

Last Update Submit

March 24, 2025

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Needle Trajectory

    Intra-operative needle trajectories in B-mode and power Doppler ultrasound

    1 month following data collection

Study Arms (1)

Patient

OTHER

Patient undergoing standard care prostate high dose rate brachytherapy.

Device: Prostate Brachytherapy

Interventions

Prostate BrachytherapyDEVICE

High dose - rate (HDR) brachytherapy

Patient

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male, aged 18 years or older
  • Willing to provide written consent
  • Pathologically confirmed prostate cancer on previous biopsy
  • Suitable for and consenting to high-dose-rate brachytherapy for treatment as standard of care.

You may not qualify if:

  • Previous radiotherapy to the prostate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Victoria Hospital

London, Ontario, N6A 5W9, Canada

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aaron Fenster

CONTACT

5199315777afenster@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Biophysics Professor

Study Record Dates

First Submitted

February 28, 2019

First Posted

March 4, 2019

Study Start

March 4, 2020

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

March 28, 2025

Record last verified: 2025-03

Locations

CA(1)