Focal radiotherapy for men with recurrent prostate cancer
Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Royal North Shore Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Leonards, New South Wales) |
| Trial ID | NCT03073278 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown promise with similar focal radiotherapy approaches, indicating potential for success in this area.
Eligibility criteria
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 this trial is running
St Leonards, New South Wales
- 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
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.