Trial summary
This study aims to evaluate the feasibility of inserting Tutelix (perirectal spacer) to reduce the dose of radiation to the rectum during radiotherapy for prostate cancer.
Who is it for?
You may be eligible for this study if you are a male with histologically proven low to intermediate risk prostate cancer, life expectancy greater than 10 years, and fit for Tutelix insertion as determined by radiation. For participants in cohort 1, you must be suitable for LDR brachytherapy for cohort 2 you must be suitable for EBRT.
Participants will receive Tutelix solution injected through a fine gauge needle and forms a cohesive hydrogel matrix upon administration. In cohort 1, participants will receive LDR brachytherapy 145Gy with lodine 125 permanent seeds as part of definitive RT for prostate cancer. For Cohort 2, participants will receive 60Gy in 20 fractions as part of definitive RT for prostate cancer.
Post Tutelix insertion participants will be assessed for dose of radiation, dosimetry, toxicity, and product performance.
It is hoped the findings from the study will show the reduction in radiation exposure will decrease bowel-related side effects of gastrointestinal symptoms, as well as an improvement in patients’ bowel-related quality of life.
Trial details
Short title
TUTELA / TUT-001A
Diagnosis
Prostate cancer
Type of treatment
Radiation Oncology
Phase
N/A
Locations
Who can participate
Clinical trials can have restrictive criteria of who can and can’t participate, talk to your healthcare provider if you are interested in this clinical trial.