How to cite: Gomella PT. “Evidence Update in Focal Therapy: 2025.” Grand Rounds in Urology. October, 2025. Accessed Oct 2026. https://grandroundsinurology.com/evidence-update-in-focal-therapy-2025/
Summary
Patrick T. Gomella, MD, MPH, FACS, Assistant Professor of Urology and Surgery, Co-Director Comprehensive Prostate Cancer Focal Therapy Program, Sidney Kimmel Comprehensive Cancer Center, Thomas Jefferson University, Philadelphia, Pennsylvania, presents a focused update on evidence in focal therapy for prostate cancer. He begins with two prospective trials that influence discussions on guidelines. The HIFI noninferiority trial compares whole gland or subtotal HIFU with radical prostatectomy. It shows similar short-term oncologic outcomes, with better functional preservation in the HIFU arm, despite the older age in that group. He highlights that this age imbalance arguably disadvantages surgery for functional results, yet HIFU still performs better.
He then reviews the PRESERVE trial of irreversible electroporation (IRE) for patients with intermediate-risk disease. Primary field biopsy clearance appears modest if all patients without protocol biopsies are counted as failures, but rises to 80% when those patients are excluded. Secondary endpoints that permit limited Grade Group 1 show an even higher success rate. Adverse events are common, but predominantly low-grade, with few events directly attributable to the procedure.
Dr. Gomella discusses the FARP randomized noninferiority trial comparing focal ablation with radical prostatectomy. Despite crossover from surgery to focal therapy, the trial meets its primary endpoint with similar treatment failure rates at three years.
He turns to newer observational and translational papers. An active surveillance cohort analysis suggests that focal therapy can reduce anxiety-driven conversion to radical treatment and prolong radical treatment-free survival. The FLAME radiotherapy trial demonstrates that a focal boost to the magnetic resonance imaging (MRI)-visible index lesion enhances biochemical control without discernible differences in survival to date.
Genomic classifier studies indicate that higher Decipher scores correlate with earlier in-field failure after focal therapy in both HIFU and cryotherapy. A medicolegal review of malpractice cases in prostate cancer ablation reveals few focal therapy suits, and most verdicts favor treating clinicians. Finally, a Swiss single-arm trial of focal HIFU shows low distress rates, stable quality of life, and declining cancer-specific anxiety over three years.
Frontiers in Oncologic Prostate Care and Ablative Local Therapy (FOCAL) is an outstanding program on prostate imaging, transperineal interventions, and ablative treatments for prostate cancer and benign prostatic hyperplasia. Bringing together community-based, academic, and industry partners, FOCAL offers lectures by world-renowned faculty and hands-on training workshops on in-office transperineal interventions, fusion-guided prostate ablation and state-of-the-art BPH management with novel technologies.
ABOUT THE AUTHOR
Patrick T. Gomella, MD, MPH, FACS, EMT-P, is an Assistant Professor of Urology at Thomas Jefferson University in Abington, Pennsylvania, where he also serves as co-director of the university’s Comprehensive Prostate Cancer Focal Therapy Program. Dr. Gomella specializes in urologic oncology and the treatment of bladder, kidney, penile, prostate, and testicular cancer. Dr. Gomella is certified by the National Registry of Emergency Medical Technicians.
