Focal radiotherapy for men with recurrent prostate cancer
Official title: Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
Run by Royal North Shore Hospital · NCT03073278 · Data updated 2026-11-12
This study is testing a new type of targeted radiation treatment for men with recurring prostate cancer to see if it's safe and effective.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 36 (estimated) |
| Sponsor | Royal North Shore Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Leonards, New South Wales) |
| Status | Recruiting |
| Started | April 24, 2017 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | February 6, 2026 |
| Trial ID | NCT03073278 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men who have had prior external beam radiotherapy and have localized recurrent prostate cancer with a life expectancy of at least 10 years.
✕Probably not a fit
Patients with recurrence near the rectum or those who have experienced severe toxicity from previous treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the feasibility, safety, and toxicity of focal stereotactic radiation treatment (SBRT) for men with locally recurrent prostate cancer. Participants will undergo a biopsy to confirm recurrence and will receive imaging scans to assess the cancer's location. The study involves inserting fiducial markers for accurate radiation targeting and may include hydrogel insertion to protect surrounding tissues. Participants will be divided into three groups, each receiving different radiation doses to evaluate safety and effectiveness.
Why it matters
Potential benefit: If successful, this treatment could provide a targeted and less toxic option for men with recurrent prostate cancer.
How similar studies have gone: Other studies have shown promise with similar focal radiotherapy approaches, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men \> 4yrs from external beam radiotherapy (EBRT) meeting the Phoenix definition of biochemical failure or men \> 5yrs from EBRT if neo-adjuvant and/or adjuvant androgen deprivation therapy (ADT) also used * Recurrence localised to less than 1 lobe of prostate on both PMSA and multi-parametric MRI (less than equal to cT2a) * Recurrence must be biopsy proven, with positive biopsies limited to the PET and MRI suspicious region. * Life expectancy at least 10yrs from time of SBRT * PSA \< 10 Exclusion Criteria: * Recurrence in immediate proximity to rectum (unless able to have hydrogel) * Grade 3 or more toxicity from previous EBRT * Contra-indicated for fiducial insertion * GS 8,9 or 10 disease previously (relative - consider if decent disease free interval)
Where it's running
-
Royal North Shore Hospital
St Leonards, New South Wales, Australia Recruiting
Study contacts
- Principal investigator: George Hruby — Northern Sydney Local Health District
- Study coordinator: Carolyn Kwong
- Email: carolyn.kwong@health.nsw.gov.au
- Phone: +61 2 9463 1339
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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.