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Updated: Jul 15, 2026
Focal Laser Ablation of Prostate Cancer: An Office Procedure
Published on: March 30, 2021
FocaSaBra: a prospective phase II study on focal salvage brachytherapy for prostate cancer recurrence after
Wojciech M Burchardt1,2, Adam Kluska1, Adam Chicheł2
1Department of Electroradiology, Poznan University of Medical Sciences, Poznan, Poland.
Background:
Recurrence of prostate cancer (PC) after primary radiotherapy poses a significant therapeutic challenge. While whole-gland salvage treatments carry considerable toxicity risks, focal salvage brachytherapy (FsBT) may preserve quality of life while achieving local control. The FocaSaBra trial is a prospective phase II study designed to evaluate the safety, feasibility, and oncologic efficacy of FsBT.
Materials And Methods:
100 patients with intraprostatic recurrence confirmed by biopsy will be enrolled to the monocentric prospective trial. Depending on the primary radiation modality, patients will receive either high-dose-rate (HDR) FsBT with 26 Gy in 2 fractions using iridium-192 or ultra-low-dose-rate (uLDR) FsBT with iodine-125 seeds delivering 145 Gy. The dominant intraprostatic lesion (DIL) will be targeted with a 5-10 mm margin. The primary endpoint is the incidence of grade ≥ 3 genitourinary (GU) or gastrointestinal (GI) toxicity, assessed using CTCAE v4.0, RTOG scale, IPSS, IIEF, and EORTC QLQ-C30/PR25. Secondary endpoints include biochemical control and progression-free survival.
Results:
Toxicity and oncological outcomes will be analyzed using descriptive statistics and multivariate modeling. Kaplan-Meier analysis will assess PSA progression-free survival. Subgroup analyses will explore the impact of prior radiation type and treatment volume. The estimated 95% confidence interval for the primary endpoint allows for adequate detection of clinically significant toxicity rates.
Conclusions:
FocaSaBra is a prospective trial to assess FsBT in radiorecurrent PC. It addresses a critical gap in salvage treatment options by potentially offering effective local control with minimal toxicity. Findings from this study may establish FsBT as a viable alternative to whole-gland salvage approaches.