Hemiablative Focal Low Dose Rate Brachytherapy: A Phase II Trial Protocol.
BACKGROUND
The objective of focal brachytherapy (BT) is to provide effective prostate cancer control for low-risk disease but with reduced genitourinary, gastrointestinal and sexual side effects in a cost-effective way.


OBJECTIVE
The aim of this study is to describe a phase II study examining technical and dosimetric feasibility and toxicity, quality of life changes, and local control with post-treatment biopsy outcomes in men with early stage low volume prostate cancer treated with focal iodine-125 seed BT.


METHODS
The study design is a prospective, multicenter trial with a planned sample size of 20 patients including men with a minimum age of 60 years, a life expectancy estimated to be greater than 10 years, with low or low-tier intermediate risk prostate cancer, unilateral disease on the biopsy, and a Gleason score of ≤3+4 and <25% cores involved. The investigations specific for the study are multi-parametric magnetic resonance imaging (Mp-MRI) baseline, at 20 and 36 months to rule out high grade disease and a transperineal mapping biopsy (baseline and at 36 months) for more accurate patient selection. The hemigland region will receive 144 Gy. Standard normal tissue constraints will be considered as for a whole gland (WG) implant. Dosimetric parameters will be evaluated at day 30 after the implant. Toxicity and quality of life will be evaluated with international validated questionnaires focusing on urinary, rectal, sexual domain, and general health-related quality of life. The patients will complete this assessment at baseline and then approximately every 6 months after the implant up to 10 years.


RESULTS
To date, one patient is involved in the trial. He underwent the pre-implant investigations which found bilateral disease. Therefore, a standard seed implant was performed. If the results from this trial provide evidence that the treatment is safe, feasible, and improves toxicity, funding will be sought to conduct a large, multicenter, randomized controlled trial (RCT).


CONCLUSIONS
This protocol is designed to show feasibility in delivering hemigland focal therapy with seed BT. It may answer crucial questions and obtain data which will enable downstream decisions on focal low dose rate (LDR) prostate BT.


BACKGROUND
Clinicaltrial.gov NCT02643511; https://www.clinicaltrials.gov/ct2/show/NCT02643511 (Archived by Webcite at http://www.webcitation.org/6ghLCzIhY).
Cancer Care Centre, Radiation Oncology, St George Hospital, Sydney, Australia. anukiots@hotmail.com.
Ana
http://orcid.org/0000-0002-0726-0409
A
Fernandez Ots
Joseph
http://orcid.org/0000-0002-8992-8301
J
Bucci
Yaw Sinn
http://orcid.org/0000-0003-0186-0371
YS
Chin
David
http://orcid.org/0000-0002-6680-2239
D
Malouf
Andrew
http://orcid.org/0000-0002-6780-2791
A
Howie
Komiti Ese
http://orcid.org/0000-0003-0235-8295
KE
Enari
cancer research; focal therapy; prostate