To assess the oncological and functional outcomes of focal high-intensity focused ultrasound (HIFU) in treating localized prostate cancer (PCa), a 3-year prospective study was undertaken using periodic post-ablation saturation biopsies.
Men with ≤ 2 lesions of grade group (GG) ≤ 3 PCa were eligible for participation. Additional criteria included a PSA ≤15 ng/mL, cT1c-T2, and a life expectancy of ≥10 years. The primary endpoint was failure-free survival (FFS), defined as absence of clinically significant PCa in-field or out-of-field on protocol-mandated saturation biopsy, no whole-gland or systemic salvage treatment, PCa metastasis, or PCa related death. Results are reported using two distinct definitions of csPCa: (1) the presence of any GG≥2 and (2) any GG≥3 or core involvement of ≥6 mm. Secondary endpoints were functional patient-reported outcome measurements addressing urinary, sexual, and bowel function.
91 patients were included; 6 (7%) with GG1 and 85 (93%) with GG≥2. 83 (91%) underwent at least 1 follow-up biopsy. Biopsy attendance at 6, 12, and 36 months was 84%, 67%, and 51%, respectively. FFS at these timepoints for any GG≥2 PCa was 79% (95% CI 80-88%), 57% (95%CI 48-69%) and 44% (95%CI 34-56%), respectively. Using the second definition, FFS were 88% (95%CI 81-95%), 70% (95%CI 61-81%) and 65% (95%CI 55-77%), respectively. The 3-year cancer-specific survival was 100%, and freedom from metastasis was 99%. MRI (NPV of up to 89%, 95%CI 84-93%) and relative decrease of PSA values (p=0.4) performed poorly in detecting residual disease. Urinary and bowel assessment returned to baseline questionnaire scores within 3 months. 17 (21%) patients experienced meaningful worsening in erectile function. A significant decrease of PCa related anxiety was observed.
Focal HIFU treatment for localized PCa shows excellent functional outcomes with half of the patients remaining cancer-free after 3 years. Whole-gland treatment was avoided in 81%. Early follow-up biopsies are crucial to change or continue the treatment modality at the right time, while the use of MRI and PSA in detecting PCa recurrence is uncertain.
BJU international. 2023 Oct 27 [Epub ahead of print]
Basil Kaufmann, Elisa Raess, Florian A Schmid, Uwe Bieri, Thomas Scherer, Moustafa Elleisy, Olivio F Donati, Niels J Rupp, Holger Moch, Michael A Gorin, Ashkan Mortezavi, Daniel Eberli
Department of Urology, University Hospital of Zurich, Switzerland., Institute of Diagnostic and Interventional Radiology, University Hospital of Zurich, Switzerland., Department of Pathology and Molecular Pathology, University Hospital of Zurich, Switzerland., Milton and Carroll Petrie Department of Urology, Icahn School of Medicine at Mount Sinai, New York, USA., Department of Urology, University Hospital of Basel, Switzerland.