Adaptive radiation for prostate cancer
Official title: Prostate Adaptive Radiation Therapy
Run by Royal North Shore Hospital · NCT06547398 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 130 (estimated) |
| Sponsor | Royal North Shore Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Leonards, New South Wales) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | October 31, 2029 |
| Study ends | October 31, 2031 |
| Registry record updated | February 5, 2026 |
| Trial ID | NCT06547398 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.