Prostate high dose-rate brachytherapy as monotherapy for low and intermediate-risk prostate cancer: Efficacy results from a randomized phase II clinical trial of one fraction of 19 Gy or two fractions of 13.5 Gy: A 9-year update.

BACKGROUND AND PURPOSE

High dose-rate (HDR) brachytherapy as a monotherapy is an accepted treatment for localized prostate cancer, but the optimal dose and fractionation schedule remain unknown. We report on the efficacy of a randomized Phase II trial comparing HDR monotherapy delivered as 27 Gy in 2 fractions vs. 19 Gy in 1 fraction with a median follow-up of 9 years.

MATERIALS AND METHODS

Enrolled patients had low or intermediate-risk disease, <60 cc prostate volume and no androgen deprivation use. Patients were randomized to 27 Gy in 2 fractions delivered one week apart vs a single fraction of 19 Gy.

RESULTS

170 patients were randomized: median age 65 years, median follow-up 107 months and median baseline PSA 6.35 ng/ml. NCCN risk categories comprised low (19 %), favourable (51 %), and unfavourable intermediate risk (30 %). The median PSA at 8 years was 0.08 ng/ml in the 2-fraction arm vs. 0.89 ng/ml in the single-fraction arm. The cumulative incidence of local failure at 8 years was 11.2 % in the 2-fraction arm vs. 35.9 % in the single-fraction arm (p < 0.001). The incidence of distant failure at 8 years was 3.8 % in the 2-fraction arm and 2.5 % in the single-fraction arm (p = 0.6).

CONCLUSIONS

HDR monotherapy delivered in two fractions of 13.5 Gy demonstrated a persistent cancer control rate at 8 years and was well-tolerated. Single-fraction monotherapy yielded poor oncologic control and is not recommended. These findings contribute to the ongoing discourse on optimal HDR monotherapy strategies for low and intermediate-risk prostate cancer.

Informations de copyright

Copyright © 2024. Published by Elsevier B.V.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [John M. Hudson – No conflicts of interest relevant to the work presented. Andrew Loblaw – No conflicts of interest relevant to the work presented. Merrylee McGuffin – No conflicts of interest relevant to the work presented. Hans T. Chung – No conflicts of interest relevant to the work presented. Chia-Lin Tseng – Advisor/consultant with Abbvie. Joelle Helou – No conflicts of interest relevant to the work presented. Patrick Cheung – No conflicts of interest relevant to the work presented. Ewa Szumacher – No conflicts of interest relevant to the work presented. Stanley Liu – No conflicts of interest relevant to the work presented. Liying Zhang – No conflicts of interest relevant to the work presented. Andrea Deabreu – No conflicts of interest relevant to the work presented. Alexandre Mamedov – No conflicts of interest relevant to the work presented. Gerard Morton reports that financial support was provided by Canadian Association of Radiation Oncology].