ArticleReports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology2026
FocaSaBra: a prospective phase II study on focal salvage brachytherapy for prostate cancer recurrence after radiotherapy - trial design.
Article in Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
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 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.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.