Trial reportBJU international2026
Focal therapy using a novel cooled laser device for prostate cancer: early trial results.
Trial report in BJU international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
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Authors and funding
18 authors.
Funding
Abstract
objectivesTo determine the short-term oncological results and safety of the ProFocal Laser Therapy for Prostate Tissue Ablation (PFLT-PC) trial, the first phase II clinical trial of ProFocal® (Medlogical Innovations, Sydney, Australia), a novel, cooled laser focal therapy (cLFT) device for prostate cancer (PCa) treatment. PATIENTS AND
methodsMen with localised PCa, prostate-specific antigen (PSA) level ≤15 ng/mL, T stage ≤T2c, International Society of Urological Pathology (ISUP) score 2-3 concordant with multiparametric magnetic resonance imaging (mpMRI) visible disease were recruited for this trial (Australian and New Zealand Clinical Trial Registry [ACTRN]12618001774213p) at Nepean Hospital, Australia. The cLFT was performed under general anaesthesia as a day procedure. Primary outcome was adequacy of tissue ablation assessed by mpMRI within 72 h and biopsy at 3 months. Secondary outcomes of functional measures were assessed using validated questionnaires (International Prostate Symptom Score, Sexual Health Inventory for Men [SHIM], Expanded Prostate cancer Index Composite [EPIC], 12-item Short-Form Health Survey). Complications and adverse events within 90 days were reported using Clavien-Dindo classification grading.
resultsA total of 100 patients were recruited. The median (interquartile range [IQR]) age was 66 (60-72) years, PSA level 5.9 (3.9-7.6) ng/mL, prostate volume 39 (30-51) mL and MRI lesion volume 0.84 (0.57-1.2) mL. The median (IQR) treatment time was 60 (47-70) min. In all, 84% had no ISUP Grade Group ≥2 PCa in their 3-month treatment zone biopsies. Erectile dysfunction was reported in 12% of the men, with a 15% mean decline in the SHIM and EPIC-sexual domains scores. There was a 4.5% decrease on EPIC-urinary domain scores. There was no decline in any other functional measures. This study's main limitations were the absence of a control group and the short follow-up.
conclusionsThe PFLT-PC trial demonstrates that at 3 months, cLFT using the ProFocal device provides an 84% treatment success with low morbidity.
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