What question did this study set out to answer?

To assess the safety and efficacy of focal salvage brachytherapy (FsBT) for prostate cancer recurrence post-radiotherapy.

April 14, 2026Open Access

FocaSaBra: a prospective phase II study on focal salvage brachytherapy for prostate cancer recurrence after radiotherapy — trial design

WBWojciech M. BurchardtGreater Poland Cancer Center AKAdam Kluska ACAdam ChichełGreater Poland Cancer Center

Key Points

To assess the safety and efficacy of focal salvage brachytherapy (FsBT) for prostate cancer recurrence post-radiotherapy.
Enrolling 100 patients with confirmed intraprostatic recurrence, assessed via biopsy.
Patients receiving either high-dose-rate or ultra-low-dose-rate FsBT, targeting the dominant lesion.
Evaluating grade ≥ 3 genitourinary or gastrointestinal toxicity through established scales.
Expected to identify clinically significant rates of toxicity and efficacy of FsBT.
Potential for improved local control with less toxicity compared to whole-gland treatments.

Abstract

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 Ir-192 or ultra-low-dose-rate (uLDR) FsBT with I-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 the first 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.

KI fragen

Bookmark

View Full Paper