PMID- 33037765
OWN - NLM
STAT- MEDLINE
DCOM- 20210920
LR  - 20210920
IS  - 1464-410X (Electronic)
IS  - 1464-4096 (Linking)
VI  - 127
IP  - 5
DP  - 2021 May
TI  - Magnetic resonance imaging-guided transurethral ultrasound ablation in patients 
      with localised prostate cancer: 3-year outcomes of a prospective Phase I study.
PG  - 544-552
LID - 10.1111/bju.15268 [doi]
AB  - OBJECTIVES: To report the 3-year follow-up of a Phase I study of magnetic 
      resonance imaging (MRI)-guided transurethral ultrasound ablation (TULSA) in 30 
      men with localised prostate cancer. Favourable 12-month safety and ablation 
      precision were previously described. PATIENTS AND METHODS: As a mandated safety 
      criterion, TULSA was delivered as near whole-gland ablation, applying 3-mm 
      margins sparing 10% of peripheral prostate tissue in 30 men. After 12-month 
      biopsy and MRI, biannual follow-up included prostate-specific antigen (PSA), 
      adverse events (AEs), and functional quality-of-life assessment, with repeat 
      systematic biopsy at 3 years. RESULTS: A 3-year follow-up was completed by 22 
      patients. Between 1 and 3 years, there were no new serious or severe AEs. Urinary 
      and bowel function remained stable. Erectile function recovered by 1 year and was 
      stable at 3 years. The PSA level decreased 95% to a median (interquartile range) 
      nadir of 0.33 (0.1-0.4) ng/mL, stable to 0.8 (0.4-1.6) ng/mL at 3 years. Serial 
      biopsies identified clinically significant disease in 10/29 men (34%) and any 
      cancer in 17/29 (59%). By 3 years, seven men had recurrence (four histological, 
      three biochemical) and had undergone salvage therapy without complications 
      (including six prostatectomies). At 3 years, three of 22 men refused biopsy, and 
      two of the 22 (9%) had clinically significant disease (one new, one persistent). 
      Predictors of salvage therapy requirement included less extensive ablation 
      coverage and higher PSA nadir. CONCLUSION: With 3-year Phase I follow-up, TULSA 
      demonstrates safe and precise ablation for men with localised prostate cancer, 
      providing predictable PSA and biopsy outcomes, without affecting functional 
      abilities or precluding salvage therapy.
CI  - (c) 2020 The Authors BJU International (c) 2020 BJU International Published by John 
      Wiley & Sons Ltd.
FAU - Nair, Shiva M
AU  - Nair SM
AUID- ORCID: 0000-0002-1075-3730
AD  - London Health Sciences Centre, Western University, London, ON, Canada.
FAU - Hatiboglu, Gencay
AU  - Hatiboglu G
AUID- ORCID: 0000-0003-0913-8420
AD  - German Cancer Research Center, University Hospital, Heidelberg, Germany.
FAU - Relle, James
AU  - Relle J
AD  - Beaumont Health System, Royal Oak, MI, USA.
FAU - Hetou, Khalil
AU  - Hetou K
AD  - London Health Sciences Centre, Western University, London, ON, Canada.
FAU - Hafron, Jason
AU  - Hafron J
AD  - Beaumont Health System, Royal Oak, MI, USA.
FAU - Harle, Christopher
AU  - Harle C
AD  - London Health Sciences Centre, Western University, London, ON, Canada.
FAU - Kassam, Zahra
AU  - Kassam Z
AD  - London Health Sciences Centre, Western University, London, ON, Canada.
FAU - Staruch, Robert
AU  - Staruch R
AD  - Profound Medical Inc, Toronto, ON, Canada.
FAU - Burtnyk, Mathieu
AU  - Burtnyk M
AD  - Profound Medical Inc, Toronto, ON, Canada.
FAU - Bonekamp, David
AU  - Bonekamp D
AD  - German Cancer Research Center, University Hospital, Heidelberg, Germany.
FAU - Schlemmer, Heinz-Peter
AU  - Schlemmer HP
AD  - German Cancer Research Center, University Hospital, Heidelberg, Germany.
FAU - Roethke, Matthias C
AU  - Roethke MC
AD  - German Cancer Research Center, University Hospital, Heidelberg, Germany.
FAU - Mueller-Wolf, Maya
AU  - Mueller-Wolf M
AD  - German Cancer Research Center, University Hospital, Heidelberg, Germany.
FAU - Pahernik, Sascha
AU  - Pahernik S
AD  - German Cancer Research Center, University Hospital, Heidelberg, Germany.
FAU - Chin, Joseph L
AU  - Chin JL
AD  - London Health Sciences Centre, Western University, London, ON, Canada.
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20201101
PL  - England
TA  - BJU Int
JT  - BJU international
JID - 100886721
RN  - EC 3.4.21.77 (Prostate-Specific Antigen)
SB  - IM
CIN - Nat Rev Urol. 2021 Jan;18(1):5-6. PMID: 33244176
MH  - Aged
MH  - Biopsy, Large-Core Needle
MH  - Erectile Dysfunction/etiology
MH  - Follow-Up Studies
MH  - *High-Intensity Focused Ultrasound Ablation/adverse effects
MH  - Humans
MH  - Male
MH  - Minimally Invasive Surgical Procedures/adverse effects
MH  - Neoplasm Recurrence, Local/*diagnosis/pathology
MH  - Penile Erection
MH  - Postoperative Complications/etiology
MH  - Prostate-Specific Antigen/blood
MH  - Prostatic Neoplasms/blood/pathology/*surgery
MH  - Quality of Life
MH  - Recovery of Function
MH  - Salvage Therapy
MH  - Surgery, Computer-Assisted/adverse effects
MH  - Urethra
MH  - Urinary Retention/etiology
OTO - NOTNLM
OT  - #PCSM
OT  - #ProstateCancer
OT  - #uroonc
OT  - Phase 1 clinical trial
OT  - image-guided intervention
OT  - magnetic resonance imaging
OT  - minimally invasive
OT  - prostate cancer
OT  - transurethral
OT  - ultrasound ablation
EDAT- 2020/10/11 06:00
MHDA- 2021/09/21 06:00
CRDT- 2020/10/10 05:37
PHST- 2020/10/11 06:00 [pubmed]
PHST- 2021/09/21 06:00 [medline]
PHST- 2020/10/10 05:37 [entrez]
AID - 10.1111/bju.15268 [doi]
PST - ppublish
SO  - BJU Int. 2021 May;127(5):544-552. doi: 10.1111/bju.15268. Epub 2020 Nov 1.