MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: A phase 2b, multicentre study Journal Article
| Authors: | Ehdaie, B.; Tempany, C. M.; Holland, F.; Sjoberg, D. D.; Kibel, A. S.; Trinh, Q. D.; Durack, J. C.; Akin, O.; Vickers, A. J.; Scardino, P. T.; Sperling, D.; Wong, J. Y. C.; Yuh, B.; Woodrum, D. A.; Mynderse, L. A.; Raman, S. S.; Pantuck, A. J.; Schiffman, M. H.; McClure, T. D.; Sonn, G. A.; Ghanouni, P. |
| Article Title: | MRI-guided focused ultrasound focal therapy for patients with intermediate-risk prostate cancer: A phase 2b, multicentre study |
| Abstract: | Background: Men with grade group 2 or 3 prostate cancer are often considered ineligible for active surveillance; some patients with grade group 2 prostate cancer who are managed with active surveillance will have early disease progression requiring radical therapy. This study aimed to investigate whether MRI-guided focused ultrasound focal therapy can safely reduce treatment burden for patients with localised grade group 2 or 3 intermediate-risk prostate cancer. Methods: In this single-arm, multicentre, phase 2b study conducted at eight health-care centres in the USA, we recruited men aged 50 years and older with unilateral, MRI-visible, primary, intermediate-risk, previously untreated prostate adenocarcinoma (prostate-specific antigen ≤20 ng/mL, grade group 2 or 3; tumour classification ≤T2) confirmed on combined biopsy (combining MRI-targeted and systematic biopsies). MRI-guided focused ultrasound energy, sequentially titrated to temperatures sufficient for tissue ablation (about 60–70°C), was delivered to the index lesion and a planned margin of 5 mm or more of normal tissue, using real-time magnetic resonance thermometry for intraoperative monitoring. Co-primary outcomes were oncological outcomes (absence of grade group 2 and higher cancer in the treated area at 6-month and 24-month combined biopsy; when 24-month biopsy data were not available and grade group 2 or higher cancer had occurred in the treated area at 6 months, the 6-month biopsy results were included in the final analysis) and safety (adverse events up to 24 months) in all patients enrolled in the study. This study is registered with ClinicalTrials.gov, NCT01657942, and is no longer recruiting. Findings: Between May 4, 2017, and Dec 21, 2018, we assessed 194 patients for eligibility and treated 101 patients with MRI-guided focused ultrasound. Median age was 63 years (IQR 58–67) and median concentration of prostate-specific antigen was 5·7 ng/mL (IQR 4·2–7·5). Most cancers were grade group 2 (79 [78%] of 101). At 24 months, 78 (88% [95% CI 79–94]) of 89 men had no evidence of grade group 2 or higher prostate cancer in the treated area. No grade 4 or grade 5 treatment-related adverse events were reported, and only one grade 3 adverse event (urinary tract infection) was reported. There were no treatment-related deaths. Interpretation: 24-month biopsy outcomes show that MRI-guided focused ultrasound focal therapy is safe and effectively treats grade group 2 or 3 prostate cancer. These results support focal therapy for select patients and its use in comparative trials to determine if a tissue-preserving approach is effective in delaying or eliminating the need for radical whole-gland treatment in the long term. Funding: Insightec and the National Cancer Institute. © 2022 Elsevier Ltd |
| Keywords: | adult; human tissue; treatment response; aged; middle aged; major clinical study; clinical trial; histopathology; cancer localization; treatment duration; treatment planning; united states; nuclear magnetic resonance imaging; follow up; magnetic resonance imaging; cancer grading; prospective study; prospective studies; prostate specific antigen; quality of life; phase 2 clinical trial; pathology; diagnostic imaging; oncology; prostate cancer; prostate-specific antigen; prostatic neoplasms; prostate; intraoperative period; urine incontinence; multicenter study; prostate tumor; prostate biopsy; patient safety; urinary tract infection; temperature; prostate adenocarcinoma; clinical effectiveness; urogenital system; regression analysis; energy; erectile dysfunction; ablation therapy; penis erection; intermediate risk patient; clinical outcome; thermometry; health center; procedures; humans; human; male; article; urethra stenosis; mr-guided focused ultrasound; international consultation on incontinence questionnaire urinary incontinence short form |
| Journal Title: | Lancet Oncology |
| Volume: | 23 |
| Issue: | 7 |
| ISSN: | 1470-2045 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2022-07-01 |
| Start Page: | 910 |
| End Page: | 918 |
| Language: | English |
| DOI: | 10.1016/s1470-2045(22)00251-0 |
| PUBMED: | 35714666 |
| PROVIDER: | scopus |
| PMCID: | PMC9400094 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 August 2022 -- Source: Scopus |
Altmetric
Citation Impact
BMJ Impact Analytics
Related MSK Work