Magnetic resonance guided focused high frequency ultrasound ablation for focal therapy in prostate cancer – phase 1 trial

• Published in: European radiology 2018-10, Vol.28 (10), p.4281-4287
• Main Authors: Ghai, Sangeet, Perlis, Nathan, Lindner, Uri, Hlasny, Eugen, Haider, Masoom A., Finelli, Antonio, Zlotta, Alexandre R., Kulkarni, Girish S., van der Kwast, Theodorus H., McCluskey, Stuart A., Kucharczyk, Walter, Trachtenberg, John
• Format: Article
• Language: English
• Subjects: Ablation; Aged; Biopsy; Cancer; Cancer surgery; Diagnostic Radiology; Feasibility studies; Health risks; High frequencies; High-Intensity Focused Ultrasound Ablation - methods; Humans; Imaging; Informed consent; Internal Medicine; Interventional Radiology; Lesions; Life assessment; Magnetic resonance imaging; Magnetic Resonance Imaging, Interventional - methods; Male; Medical treatment; Medicine; Medicine & Public Health; Middle Aged; Neoplasm Grading; Neuroradiology; Oncology; Patients; Prospective Studies; Prostate cancer; Prostatectomy; Prostatectomy - methods; Prostatic Neoplasms - pathology; Prostatic Neoplasms - surgery; Quality of Life; Radiology; Resonance; Risk; Sonication; Surgery; Surgery, Computer-Assisted - methods; Therapy; Ultrasonic imaging; Ultrasonic testing; Ultrasonography; Ultrasound; Urological surgery
• ISSN: 0938-7994; 1432-1084
• DOI: 10.1007/s00330-018-5409-z

Objectives To evaluate the feasibility and safety of focal therapy for low–intermediate risk prostate cancer (PCa) with magnetic resonance-guided high frequency focused ultrasound (MRgFUS) Methods This IRB-approved phase 1 prospective study enrolled eight patients with prostate specific antigen (PSA) ≤ 10 ng/ml, ≤ cT2a and Gleason score ≤ 7 (4 + 3) disease following informed consent. Under MRI guidance, focused high frequency ultrasound energy was delivered to ablate the target tissue. Treatment-related adverse events were recorded. Oncologic outcomes were evaluated with multiparametric MRI, PSA and TRUS biopsy at 6 months following treatment. Results Ten target lesions [six Gleason 6 lesions, two Gleason 7 (3 + 4) and two Gleason 7 (4 + 3)] were treated in eight men (prostate volume range, 25–50 cc; mean MRI time, 248 min per patient; mean sonication duration, 65 min). Mean target volume was 2.7 cc and mean post-treatment non-perfused volume was 4.3 cc. Quality of life parameters were similar between baseline and 6 months in 6/8 patients. All treated regions were negative on MRI; 4/8 patients and 6/10 target lesions (60%) were clear of disease on biopsy. One patient with 2-mm Gleason 8 disease in one of five cores from treatment site (4 + 3 disease at baseline) subsequently underwent prostatectomy with negative surgical margins. Three patients with low volume (5–15%) Gleason 6 residual disease were offered active surveillance. Mean PSA decreased from 5.06 at baseline to 3.4 ng/ml at 6 months. Conclusion MRgFUS is a feasible and safe method of noninvasively ablating low–intermediate risk PCa with acceptable short-term oncologic outcomes. Key Points • Focal therapy selectively ablates locally confined, clinically significant index lesion with a margin while sparing rest of gland and adjacent vital structures. • Magnetic resonance-guided focused high frequency ultrasound surgery (MRgFUS) combines MRI with HIFU. • MRgFUS provides ability to monitor treatments in real time and allows a targeted approach for focal ablation. • MRgFUS is a feasible, safe method of noninvasively ablating low–intermediate risk PCa. • MRgFUS provides acceptable oncologic outcomes at 6 months.