Comparing different radiotherapy techniques for prostate cancer treatment
Optimal Prostate Fractionation Study
NA · Royal North Shore Hospital · NCT03386045
This study is testing three different types of radiotherapy for prostate cancer to see which one causes fewer side effects and helps patients feel better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Royal North Shore Hospital (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (St Leonards, New South Wales) |
| Trial ID | NCT03386045 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the toxicity, local control rates, biochemical failure rates, and quality of life associated with three distinct radiotherapy techniques for prostate cancer: moderate hypofractionation, stereotactic body radiotherapy (SBRT), and standard radiotherapy combined with SBRT (BOOSTER). Participants with histologically confirmed prostate adenocarcinoma will be randomized into two groups, with one group receiving either moderate hypofractionation or standard radiotherapy plus SBRT, while the other group will receive either moderate hypofractionation or SBRT alone. The study will also involve the use of fiducial markers and hydrogel to enhance treatment accuracy and minimize side effects. A Safety Committee will monitor adverse events throughout the trial.
Who should consider this trial
Good fit: Ideal candidates include men with histologically proven prostate adenocarcinoma who are suitable for high dose radiotherapy and meet specific eligibility criteria.
Not a fit: Patients who have previously undergone pelvic radiotherapy or total prostatectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment outcomes and quality of life for patients with prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar radiotherapy approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Histologically proven prostate adenocarcinoma * PSA obtained within three months prior to enrolment * ECOG performance status 0 to 2 * Ability to understand and the willingness to sign a written consent * Suitable for high dose irradiation to the prostate To be eligible for the arm containing Stereotactic Booster alone approach patient must have the following * No contraindication to MRI such as pacemaker and severe claustrophobia * Patient must be able to have fiducial markers placed in the prostate * Patient must be able to have hydrogel insertion at the same time as fiducial markers * Must have IPSS less than 15 Exclusion criteria * Previous pelvic radiotherapy * Prior total prostatectomy * Unwilling or unable to give informed consent
Where this trial is running
St Leonards, New South Wales
- Royal North Shore Hospital — St Leonards, New South Wales, Australia (RECRUITING)
Study contacts
- Principal investigator: Andrew Kneebone, MBBS — Northern Sydney Local Health District
- Study coordinator: Carol Kwong
- Email: carolyn.kwong@health.nsw.gov.au
- Phone: +61 2 9463 1339
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