Monitoring prostate movement during radiotherapy
Phase I Feasibility Study of Prostate Cancer Radiotherapy Gating Using kV Intrafraction Monitoring (KIM)
NA · Royal North Shore Hospital · NCT01742403
This study tests if using tiny gold markers can help track prostate movement during radiation therapy to make sure patients with prostate cancer get the right amount of treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | Male |
| Sponsor | Royal North Shore Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (St. Leonards, New South Wales) |
| Trial ID | NCT01742403 on ClinicalTrials.gov |
What this trial studies
This study investigates the measurement of prostate motion during radiotherapy using implanted gold markers. It aims to address intrafraction motion, which occurs after the initial treatment setup and can lead to significant errors in radiation dose delivery. By continuously monitoring prostate position, the study seeks to stop the radiation beam and correct the position if motion exceeds 3mm. This approach could enhance the precision of radiation therapy for prostate cancer patients.
Who should consider this trial
Good fit: Ideal candidates are men with histologically proven prostate adenocarcinoma who are undergoing definitive external beam radiotherapy.
Not a fit: Patients with altered fractionation or those who cannot have gold fiducial markers placed may not benefit from this study.
Why it matters
Potential benefit: If successful, this could lead to more accurate radiation delivery and improved treatment outcomes for prostate cancer patients.
How similar studies have performed: Other studies have shown success with similar approaches in monitoring prostate motion, indicating a promising avenue for improving radiotherapy accuracy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Altered fractionation * Fiducials must be no less than 1cm apart
Where this trial is running
St. Leonards, New South Wales
- Department of Radiation Oncology, Northern Sydney Cancer Centre — St. Leonards, New South Wales, Australia (RECRUITING)
Study contacts
- Principal investigator: Thomas Eade, MBBS — Royal North Shore Hospital
- Study coordinator: Thomas N Eade, MBBS
- Email: TEade@nsccahs.health.nsw.gov.au
- Phone: +61294631319
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Prostate Cancer, Prostate, IGRT, VMAT