TY - JOUR
T1 - Cancer Control Outcomes Following Focal Therapy Using High-intensity Focused Ultrasound in 1379 Men with Nonmetastatic Prostate Cancer
T2 - A Multi-institute 15-year Experience
AU - Reddy, Deepika
AU - Peters, Max
AU - Shah, Taimur T
AU - van Son, Marieke
AU - Tanaka, Mariana Bertoncelli
AU - Huber, Philipp M
AU - Lomas, Derek
AU - Rakauskas, Arnas
AU - Miah, Saiful
AU - Eldred-Evans, David
AU - Guillaumier, Stephanie
AU - Hosking-Jervis, Feargus
AU - Engle, Ryan
AU - Dudderidge, Tim
AU - Hindley, Richard G
AU - Emara, Amr
AU - Nigam, Raj
AU - McCartan, Neil
AU - Valerio, Massimo
AU - Afzal, Naveed
AU - Lewi, Henry
AU - Orczyk, Clement
AU - Ogden, Chris
AU - Shergill, Iqbal
AU - Persad, Raj
AU - Virdi, Jaspal
AU - Moore, Caroline M
AU - Arya, Manit
AU - Winkler, Mathias
AU - Emberton, Mark
AU - Ahmed, Hashim U
N1 - Funding Information:
Financial disclosures: Deepika Reddy certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Hashim U. Ahmed’s research is supported by core funding from the National Institute of Health Research (NIHR) Imperial Biomedical Research Centre, UK. Ahmed currently receives funding from the Wellcome Trust, Medical Research Council (UK), Cancer Research UK, Prostate Cancer UK, National Institute for Health Research (UK), The Urology Foundation, BMA Foundation, Imperial Health Charity, NIHR Imperial BRC, Sonacare Inc., Trod Medical, and Sophiris Biocorp for trials in prostate cancer; and was a paid medical consultant for Sophiris Biocorp in the previous 3 yr. Mark Emberton’s research is supported by core funding from the UK’s National Institute of Health Research (NIHR) UCLH/UCL Biomedical Research Centre. Emberton was awarded NIHR Senior Investigator in 2015; receives funding from NIHR-i4i, MRC (UK), Cancer Research UK, Sonacare Inc., Trod Medical, Cancer Vaccine Institute, and Sophiris Biocorp for trials in prostate cancer; and is a medical consultant to Sonacare Inc., Sophiris Biocorp, Steba Biotech, Exact Imaging, and Profound Medical. Caroline M. Moore receives funding from the National Institute for Health Research, The European Association of Urology Research Foundation, MRC, Cancer Research UK, Prostate Cancer UK, Movember, and the Cancer Vaccine Institute, for clinical prostate cancer research; and has received advisory board fees for Genomic Health. Taimur T. Shah receives funding from Prostate Cancer UK and the St Peters Trust for clinical research, and has received funding for conference attendance from Astellas, Ferring, and Galil Medical. Hashim U. Ahmed, Mark Emberton, Richard G. Hindley, Caroline M. Moore, Manit Arya, and Tim Dudderidge are all proctors for HIFU and are paid for training other surgeons in this procedure. Hashim U. Ahmed and Manit Arya are proctors for cryotherapy and are paid for training other surgeons in this procedure. Mark Emberton is a proctor for Irreversible Electroporation (Nanoknife) and is paid for training other surgeons in this procedure. Hashim U. Ahmed and Richard G. Hindley are paid proctors for Rezum for the treatment of benign prostate hyperplasia. Mathias Winkler receives a travel grant and previously a loan of device from Zicom Biobot. Deepika Reddy was funded by a research grant from Prostate Cancer UK and received funding to attend conferences from SonaCare Inc. David Eldred-Evans received funding from the Urology Foundation, the BMA Foundation for Medical Research, Imperial Health Charity, and the Royal College of Surgeons of England.
Publisher Copyright:
© 2022 European Association of Urology
PY - 2022/4
Y1 - 2022/4
N2 - BACKGROUND: Focal therapy aims to treat areas of cancer to confer oncological control whilst reducing treatment-related functional detriment.OBJECTIVE: To report oncological outcomes and adverse events following focal high-intensity focused ultrasound (HIFU) for treating nonmetastatic prostate cancer.DESIGN, SETTING, AND PARTICIPANTS: An analysis of 1379 patients with ≥6 mo of follow-up prospectively recorded in the HIFU Evaluation and Assessment of Treatment (HEAT) registry from 13 UK centres (2005-2020) was conducted. Five or more years of follow-up was available for 325 (24%) patients. Focal HIFU therapy used a transrectal ultrasound-guided device (Sonablate; Sonacare Inc., Charlotte, NC, USA).OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Failure-free survival (FFS) was primarily defined as avoidance of no evidence of disease to require salvage whole-gland or systemic treatment, or metastases or prostate cancer-specific mortality. Differences in FFS between D'Amico risk groups were determined using a log-rank analysis. Adverse events were reported using Clavien-Dindo classification.RESULTS AND LIMITATIONS: The median (interquartile range) age was 66 (60-71) yr and prostate-specific antigen was 6.9 (4.9-9.4) ng/ml with D'Amico intermediate risk in 65% (896/1379) and high risk in 28% (386/1379). The overall median follow-up was 32 (17-58) mo; for those with ≥5 yr of follow-up, it was 82 (72-94). A total of 252 patients had repeat focal treatment due to residual or recurrent cancer; overall 92 patients required salvage whole-gland treatment. Kaplan-Meier 7-yr FFS was 69% (64-74%). Seven-year FFS in intermediate- and high-risk cancers was 68% (95% confidence interval [CI] 62-75%) and 65% (95% CI 56-74%; p = 0.3). Clavien-Dindo >2 adverse events occurred in 0.5% (7/1379). The median 10-yr follow-up is lacking.CONCLUSIONS: Focal HIFU in carefully selected patients with clinically significant prostate cancer, with six and three of ten patients having, respectively, intermediate- and high-risk cancer, has good cancer control in the medium term.PATIENT SUMMARY: Focal high-intensity focused ultrasound treatment to areas of prostate with cancer can provide an alternative to treating the whole prostate. This treatment modality has good medium-term cancer control over 7 yr, although 10-yr data are not yet available.
AB - BACKGROUND: Focal therapy aims to treat areas of cancer to confer oncological control whilst reducing treatment-related functional detriment.OBJECTIVE: To report oncological outcomes and adverse events following focal high-intensity focused ultrasound (HIFU) for treating nonmetastatic prostate cancer.DESIGN, SETTING, AND PARTICIPANTS: An analysis of 1379 patients with ≥6 mo of follow-up prospectively recorded in the HIFU Evaluation and Assessment of Treatment (HEAT) registry from 13 UK centres (2005-2020) was conducted. Five or more years of follow-up was available for 325 (24%) patients. Focal HIFU therapy used a transrectal ultrasound-guided device (Sonablate; Sonacare Inc., Charlotte, NC, USA).OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Failure-free survival (FFS) was primarily defined as avoidance of no evidence of disease to require salvage whole-gland or systemic treatment, or metastases or prostate cancer-specific mortality. Differences in FFS between D'Amico risk groups were determined using a log-rank analysis. Adverse events were reported using Clavien-Dindo classification.RESULTS AND LIMITATIONS: The median (interquartile range) age was 66 (60-71) yr and prostate-specific antigen was 6.9 (4.9-9.4) ng/ml with D'Amico intermediate risk in 65% (896/1379) and high risk in 28% (386/1379). The overall median follow-up was 32 (17-58) mo; for those with ≥5 yr of follow-up, it was 82 (72-94). A total of 252 patients had repeat focal treatment due to residual or recurrent cancer; overall 92 patients required salvage whole-gland treatment. Kaplan-Meier 7-yr FFS was 69% (64-74%). Seven-year FFS in intermediate- and high-risk cancers was 68% (95% confidence interval [CI] 62-75%) and 65% (95% CI 56-74%; p = 0.3). Clavien-Dindo >2 adverse events occurred in 0.5% (7/1379). The median 10-yr follow-up is lacking.CONCLUSIONS: Focal HIFU in carefully selected patients with clinically significant prostate cancer, with six and three of ten patients having, respectively, intermediate- and high-risk cancer, has good cancer control in the medium term.PATIENT SUMMARY: Focal high-intensity focused ultrasound treatment to areas of prostate with cancer can provide an alternative to treating the whole prostate. This treatment modality has good medium-term cancer control over 7 yr, although 10-yr data are not yet available.
KW - Humans
KW - Male
KW - Neoplasm Recurrence, Local/pathology
KW - Prostate-Specific Antigen
KW - Prostate/pathology
KW - Prostatic Neoplasms/diagnostic imaging
KW - Salvage Therapy/methods
KW - Treatment Outcome
KW - Ultrasound, High-Intensity Focused, Transrectal/adverse effects
KW - High-intensity focussed ultrasound
KW - Oncological outcomes
KW - Focal therapy
KW - Prostate cancer
UR - http://www.scopus.com/inward/record.url?scp=85123994493&partnerID=8YFLogxK
U2 - 10.1016/j.eururo.2022.01.005
DO - 10.1016/j.eururo.2022.01.005
M3 - Article
C2 - 35123819
SN - 0302-2838
VL - 81
SP - 407
EP - 413
JO - European Urology
JF - European Urology
IS - 4
ER -