Focal Radiotherapy for Previously Treated Prostate Cancer Patients
Phase I Feasibility Trial of Stereotactic Re-irradiation of Prostate Cancer Recurrence Within the Definitively Irradiated Prostate
About This Trial
- This study is testing whether a precise, highly targeted type of radiation is safe and effective for treating prostate cancer that has returned.
- It is open to men whose cancer has come back in only a small, specific part of the prostate several years after receiving their first radiation treatment.
- To qualify, you must have scans and a biopsy confirming the cancer is limited to a single area, as well as a PSA level under 10.
- Before joining, patients should know that the procedure requires placing tiny guidance markers in the prostate and is not suitable for those who experienced severe side effects from their past radiation treatments.
More Information
- To examine the feasibility, safety and toxicity of focal stereotactic radiation treatment (SBRT) for locally recurrent prostate cancer.
Who Can Enroll
- Age Range: 18 years and older
- Gender: Male
- Who This Trial is For: This study is testing whether a precise, highly targeted type of radiation is safe and effective for treating prostate cancer that has returned.
Study Details
- Start Date: April 24, 2017
- Lead Sponsor: Royal North Shore Hospital
Full Eligibility 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)
Treatments
- Radiation: Stereotactic Body Radiotherapy