Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol
Ana Fernandez Ots1, Joseph Bucci, Yaw Sinn Chin
1Cancer Care Centre, Radiation Oncology, St George Hospital, Sydney, Australia. anukiots@hotmail.com.
JMIR Research Protocols
|June 15, 2016
Summary
This study investigates focal brachytherapy (BT) for low-risk prostate cancer, aiming for effective treatment with fewer side effects. Early results suggest feasibility, paving the way for larger trials on focal low dose rate (LDR) prostate BT.
Area of Science:
- Oncology
- Radiation Oncology
- Urology
Background:
- Focal brachytherapy (BT) aims to treat low-risk prostate cancer effectively while minimizing side effects.
- This approach seeks a cost-effective solution for prostate cancer management.
Purpose of the Study:
- To assess the technical and dosimetric feasibility of focal iodine-125 seed BT in early-stage, low-volume prostate cancer.
- To evaluate toxicity, quality of life changes, and local control rates following focal BT.
- To analyze post-treatment biopsy outcomes in patients receiving focal BT.
Main Methods:
- A prospective, multicenter phase II study involving patients aged 60+ with low or low-tier intermediate-risk prostate cancer.
- Utilized multi-parametric MRI (Mp-MRI) and transperineal mapping biopsy for patient selection and disease assessment.
- Administered 144 Gy to the hemigland region, adhering to standard normal tissue constraints, with evaluations up to 10 years.
Main Results:
- One patient enrolled, presenting with bilateral disease requiring a standard seed implant, indicating the need for precise patient selection.
- The trial aims to gather data on safety, feasibility, and toxicity improvements.
Conclusions:
- The protocol is designed to demonstrate the feasibility of hemigland focal therapy using seed brachytherapy.
- Findings will inform future decisions regarding focal low dose rate (LDR) prostate BT and potentially lead to larger randomized controlled trials.
