Etten Leur

Researchers are evaluating focal therapy as a treatment for men with intermediate-risk, unilateral clinically localized prostate cancer in the Netherlands. This approach aims to selectively treat part of the prostate, preserving the rest of the gland, and may reduce complications like incontinence and erectile dysfunction compared to standard radical treatments such as prostatectomy or radiotherapy. The study is a multicenter randomized controlled trial designed to provide high-quality evidence on the oncological effectiveness, quality of life, and cost-effectiveness of focal therapy in this patient group. Participants will receive either focal therapy using ultrasound ablation (HIFU/TULSA) or irreversible electroporation (IRE) with intensive follow-up including PSA measurements quarterly and prostate MRI at 12, 24, 36, 48, and 60 months. A prostate biopsy will be performed at 12 months and when indicated by MRI findings. The comparison group will receive usual care with standard radical treatment (prostatectomy or radiotherapy) and follow-up according to international guidelines, including PSA monitoring and imaging as needed. During the study, all patients will undergo regular assessments involving PSA testing, imaging, and biopsies as required. Researchers will measure treatment failure over 36 months to assess oncological effectiveness and evaluate quality of life at 12 months using a prostate cancer-specific questionnaire. The study also tracks costs related to side effects and aims to inform reimbursement decisions and clinical guidelines. The total follow-up period extends up to five years after treatment, ensuring thorough long-term monitoring of outcomes and safety.