Adaptive radiation for prostate cancer
Prostate Adaptive Radiation Therapy
NA · Royal North Shore Hospital · NCT06547398
This study tests whether daily adaptive radiotherapy led by radiation therapists, with the option to use smaller treatment margins, can reduce side effects for men having prostate radiotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (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 | NCT06547398 on ClinicalTrials.gov |
What this trial studies
This is a two-phase, randomized program at Royal North Shore Hospital where phase 1 tests the safety and feasibility of a radiation therapist–led adaptive workflow and phase 2 tests margin-reduced adaptive treatments to lower toxicity. Treatments use image-guided, daily adaptive radiotherapy to account for anatomical changes and may reduce clinical and planning target volume margins compared with standard practice. Eligible participants are adults with biopsy-proven prostate cancer receiving definitive prostate-only radiotherapy, while patients with hip prostheses or excessive body separation are excluded. Primary endpoints are feasibility and safety in phase 1 and patient-reported and clinical toxicity outcomes in phase 2.
Who should consider this trial
Good fit: Men over 18 with biopsy-proven prostate cancer scheduled for definitive prostate radiotherapy, ECOG 0–2, able to consent, and without a hip prosthesis or excessive body separation are the intended participants.
Not a fit: Patients needing pelvic nodal irradiation, those with a hip prosthesis, or those with prostate-to-skin separation greater than 24 cm are unlikely to be eligible or to benefit from the margin-reduction approach.
Why it matters
Potential benefit: If successful, this approach could lower radiation side effects and improve quality of life by safely reducing treatment margins.
How similar studies have performed: Earlier adaptive radiotherapy studies have shown promising reductions in acute toxicity, but RT-led daily adaptive workflows and randomized margin-reduction approaches are relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. \- Age \> 18 2. Biopsy proven prostate malignancy 3. Definitive treatment is radiotherapy to the prostate alone 4. ECOG performance status 0-2 5. Ability to understand and the willingness to sign an informed consent Exclusion Criteria: 1. Hip prosthesis 2. Patient separation from prostate centre to skin edge \> 24cm, measured on diagnostic scan-
Where this trial is running
St Leonards, New South Wales
- Northern Sydney Cancer Centre, Royal North Shore Hospital — St Leonards, New South Wales, Australia (RECRUITING)
Study contacts
- Principal investigator: Andrew Prof Kneebone, MBBS — Northern Sydney Local Health District
- Study coordinator: Nada Cheikh-Ali
- Email: nada.cheikhali@health.nsw.gov.au
- Phone: +61294631345
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: Prostatic Neoplasms