Continuous Monitoring of Prostate Position During Radiotherapy

NCT01742403 | Active Not Recruiting

• 1 other identifier: 12-NSCCRO-P001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating measurement of prostate motion during radiotherapy using the implanted gold markers. If motion is greater than 3mm then the beam will be stopped and position corrected (gating).

Conditions

Prostate Cancer

Keywords

Prostate; IGRT; VMAT

Outcome Measures

Primary Outcomes (1)

• Feasibility of KIM techique

  Technique will be determined as feasible if 90% of treatment fractions are successfully segmented in real time.

  10 years

Secondary Outcomes (1)

• Time for procedure

  10 years

Study Arms (1)

R/T gating kV intrafraction monitoring

EXPERIMENTAL

Intervention: Recruitment will be performed in 2 phases: Phase I will include the first 10 patients. All patients will be treated on a standard fractionation protocol with 40 fractions. This will allow 400 potential fractions to be auto-segmented in real time. Once Phase I is successfully completed we will aim to continue recruitment of a further 20 patients as Phase II. For this phase we will open recruitment to patients with lymph node positivity, hypofractionation (as per Department protocols) and intermittent imaging (imaging less frequently than every fraction).

Radiation: R/T gating kV intrafraction monitoring

Interventions

R/T gating kV intrafraction monitoring RADIATION

This is a Phase I Pilot study to assess the feasibility of implementing prostate radiotherapy gating using kV intrafraction monitoring.

R/T gating kV intrafraction monitoring

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing definitive external beam radiotherapy;
• Histological proven prostate adenocarcinoma
• Prostate Specific Antigen (PSA),within 3 months prior to enrolment
• Patient must be able to have gold fiducial markers placed in the prostate (if on anticoagulants, must be approved for procedure by Cardiologist)
• Artificial hips
• Lymph Node irradiation
• Patient Dimensions \>40cms
• ECOG 0-2
• Ability to understand and willingness to sign informed consent form.

You may not qualify if:

• Altered fractionation
• Fiducials must be no less than 1cm apart

Sponsors & Collaborators

• Royal North Shore Hospital: lead
• Northern Sydney and Central Coast Area Health Service: collaborator

Study Sites (1)

Department of Radiation Oncology, Northern Sydney Cancer Centre

St Leonards, New South Wales, 2065, Australia

Location

Related Publications (2)

• Keall PJ, Aun Ng J, O'Brien R, Colvill E, Huang CY, Rugaard Poulsen P, Fledelius W, Juneja P, Simpson E, Bell L, Alfieri F, Eade T, Kneebone A, Booth JT. The first clinical treatment with kilovoltage intrafraction monitoring (KIM): a real-time image guidance method. Med Phys. 2015 Jan;42(1):354-8. doi: 10.1118/1.4904023.

  PMID: 25563275 RESULT

• Ng JA, Booth JT, O'Brien RT, Colvill E, Huang CY, Poulsen PR, Keall PJ. Quality assurance for the clinical implementation of kilovoltage intrafraction monitoring for prostate cancer VMAT. Med Phys. 2014 Nov;41(11):111712. doi: 10.1118/1.4898119.

  PMID: 25370626 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Thomas Eade, MBBS

  Royal North Shore Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2012
• First Posted: December 5, 2012
• Study Start: January 1, 2013
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)