Etten Leur

This research aims to evaluate focal therapy as a treatment option for men with intermediate-risk, unilateral clinically localized prostate cancer in the Netherlands. Traditional treatments like prostatectomy or radiotherapy often cause significant side effects such as incontinence and erectile dysfunction. Focal therapy targets only the cancerous part of the prostate, potentially reducing these side effects while maintaining cancer control. There is currently a lack of high-quality evidence supporting focal therapy, prompting this multi-center randomized controlled trial to assess its effectiveness, quality of life impact, and cost-effectiveness compared to usual care. Participants will be randomly assigned to receive either focal therapy using devices like TULSA, irreversible electroporation IRE, or high-intensity focused ultrasound HIFU, or usual care involving radical prostatectomy or radiotherapy. Focal therapy involves treating only the affected prostate area while preserving the rest, with follow-up including MRI scans at 12, 24, 36, 48, and 60 months, prostate biopsies when indicated, and PSA monitoring. Usual care follows standard radical treatment protocols with PSA and imaging follow-up according to guidelines. Throughout the study, participants will undergo regular assessments including PSA measurements, MRI scans, biopsies, and several quality of life questionnaires focusing on cancer-related, urinary, and sexual health outcomes. The main outcomes measured are treatment failure at 36 months and quality of life at 12 months. Secondary outcomes include metastasis-free survival, disease progression, mortality, adverse events, hospital stay, pathology results, and cost-effectiveness over 60 months. The trial includes intensive follow-up and safety monitoring, with a total participation timeline extending up to five years.