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Prospective trial on focal treatment with hemi- gland brachytherapy in low-risk prostate cancer: A negative study

Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Purpose: To determine whether hemi-gland seed brachytherapy (HGBT) is as effective as whole-gland seed brachytherapy (WGBT) in patients with single-lobe, low-risk and favorable intermediate-risk prostate cancer (PCa). Material and methods:Phase II clinical trial in patients with low-and favorable intermediate-risk PCa with HGBT.Enrolment took place between 2016 and 2020.All patients (n = 38) underwent HGBT with iodine-125 ( 125 I) seeds.Inclusion criteria: single-lobe prostate cancer, ≤ 2 positive cores in one lobe (≥ 10 core samples), < 50% core invasion, Gleason ≤ 7 (3 + 4), non-visible or unilaterally visible tumor.Patient-reported expanded prostate cancer index (EPIC-26) questionnaire was administered to assess quality of life (QoL).Treatment outcomes were compared with a historical cohort of patients (n = 700), who underwent transperineal, ultrasound-guided 125 I WGBT between 2000 and 2012.Results: The mean age was 64.9 years (range, 50-78), the mean baseline prostate-specific antigen (PSA) was 6.12 ng/ml (range, 1.53-10), and the mean nadir was 1.4 ng/ml (range, 0.17-4.24).Most patients (37/38) had Gleason 3 + 3. The mean follow-up was 71.4 months (range, 44-93).Seventeen patients developed biochemical relapse, and 14 presented local clinical progression (contralateral, n = 9, ipsilateral + contralateral, n = 4; and regional, n = 1).Salvage therapy was: contralateral low-dose-rate (LDR) BT (n = 6), high-dose-rate (HDR) BT (n = 2), nodal radiation therapy (RT) + hormonotherapy (n = 2), hormonotherapy alone (n = 1), and prostatectomy (n = 1).Thirty-five patients (92.1%) remained alive (12 with biochemical failure) at the final follow-up, while three patients died of other causes.A slight impairment was observed on all EPIC domains (urinary incontinence, urinary obstruction, bowel, sexual, and hormonal summaries).Compared with the WGBT cohort, urinary irritative/obstructive scores were significantly lower (p = 0.002).At 5 years, biochemical relapse-free survival (BRFS) was 54% in the HGBT group vs. 95% in the WGBT cohort. Conclusions:In this trial, patients treated with hemi-gland brachytherapy had significantly higher biochemical failure and contralateral relapse rates than a historical cohort of patients treated with WGBT.Larger, well-designed clinical trials are needed to better assess the efficacy of HGBT in the treatment of low-risk PCa.
Language: English
Field: Medicine
Open Access status: gold
Estimated APC paid: $269
OpenAlex ID: W4415909656
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