The PART randomised trial protocol: Partial Ablation versus Radical Treatment for prostate cancer

OBJECTIVES: Primary objective: to determine whether prostate gland partial ablation (PA) has non-inferior oncological treatment success vs radical treatment (RT) of localised intermediate-risk prostate cancer (irPCa). SECONDARY OBJECTIVES: to compare (i) participant-reported urinary and sexual dysfunction side effects, (ii) short/medium term serious adverse events, (iii) health-related quality of life (HRQoL), (iv) cost-effectiveness; and to report (v) the need for repeat PA, (vi) accuracy of magnetic resonance imaging and biopsy protocols in determining suitability for PA, (vii) disease progression, local spread and metastases, (viii) medium-term disease-specific and overall mortality. PARTICIPANTS AND METHODS: The 'Partial prostate Ablation versus Radical Treatment' (PART; International Standard Randomised Controlled Trial Number ISRCTN17249875) is a UK-wide, multicentre, pragmatic, randomised controlled trial investigating whether PA (high-intensity focused ultrasound [HIFU] or irreversible electroporation [IRE]) is non-inferior to RT (radical prostatectomy, radical radiotherapy, or low-dose-rate brachytherapy [LDR-B]) in treating localised irPCa. A Qualitative Research Integrated within Trials (QuinteT) Recruitment Intervention is included to optimise recruitment and informed consent. Primary outcome treatment success for PA will be determined by prostate biopsies and imaging, and for RT using standard definitions. Participants will receive treatment according to their randomised allocation, with HIFU or IRE for PA depending on lesion location, and radical prostatectomy, radical radiotherapy, or LDR-B according to patient and physician preference for RT. Based on 95% and 85% oncological treatment success for RT and PA, respectively, with a non-inferiority margin of 20%, at median 3 years of follow-up, PART requires 275 recruited men (137 per group, randomised on a 1:1 basis), for 80% power, with a one-sided alpha of 0.025. Allowing for a 10% total withdrawal or dropout rate, PART requires 306 recruited and randomised participants. CONCLUSIONS: The PART trial will provide robust prospective data and high-level randomised evidence to determine oncological treatment effectiveness of PA vs RT for localised irPCa, along with comparative side effect, HRQoL, and health economics evaluations, to inform clinical decision-making.

Authors

Institutions

Publication Details

Journal
British Journal of Urology
Published
2026-09-18
DOI
https://doi.org/10.1111/bju.70448
Primary Topic
Prostate Cancer Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
0.00

Funders

Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
article

The PART randomised trial protocol: Partial Ablation versus Radical Treatment for prostate cancer

J.D. Scaife, Hashim U. Ahmed, Caroline M. Moore, Abhishek D. Sharma et al.
British Journal of Urology
Prostate Cancer Diagnosis and Treatment
article

The PART randomised trial protocol: Partial Ablation versus Radical Treatment for prostate cancer

J.D. Scaife, Hashim U. Ahmed, Caroline M. Moore, Abhishek D. Sharma, Tom Leslie, Catherine R. Holt, Simon Brewster, Jonathan Cook, Taimur T. Shah, Filipa Landeiro, Prasanna Sooriakumaran, John Withington, Oliver Hulson, Aimi Hewitt, Jane Wolstenholme, Shelagh Lovell, Derek Shepherd, Richard J. Bryant, Ioana R. Marian, Martyn Hill, Vicki S Barber, Philip Camilleri, Clare Brittain, Daisy Elliott, J Donovan, Sanjeev Kotwal, Nishant Bedi, Daniel W. Good, R. Williams, Ruth MacPherson, William Cross, Marc Laniado, Clare Verrill, Martin Pirkl, Alistair Grey, Jo Cook, Edward Streeter, James Radford, Fergus Gleeson, Christopher Blick, Luke Stroman, Altan Omer, Freddie C. Hamdy
article en

Abstract

OBJECTIVES: Primary objective: to determine whether prostate gland partial ablation (PA) has non-inferior oncological treatment success vs radical treatment (RT) of localised intermediate-risk prostate cancer (irPCa). SECONDARY OBJECTIVES: to compare (i) participant-reported urinary and sexual dysfunction side effects, (ii) short/medium term serious adverse events, (iii) health-related quality of life (HRQoL), (iv) cost-effectiveness; and to report (v) the need for repeat PA, (vi) accuracy of magnetic resonance imaging and biopsy protocols in determining suitability for PA, (vii) disease progression, local spread and metastases, (viii) medium-term disease-specific and overall mortality. PARTICIPANTS AND METHODS: The 'Partial prostate Ablation versus Radical Treatment' (PART; International Standard Randomised Controlled Trial Number ISRCTN17249875) is a UK-wide, multicentre, pragmatic, randomised controlled trial investigating whether PA (high-intensity focused ultrasound [HIFU] or irreversible electroporation [IRE]) is non-inferior to RT (radical prostatectomy, radical radiotherapy, or low-dose-rate brachytherapy [LDR-B]) in treating localised irPCa. A Qualitative Research Integrated within Trials (QuinteT) Recruitment Intervention is included to optimise recruitment and informed consent. Primary outcome treatment success for PA will be determined by prostate biopsies and imaging, and for RT using standard definitions. Participants will receive treatment according to their randomised allocation, with HIFU or IRE for PA depending on lesion location, and radical prostatectomy, radical radiotherapy, or LDR-B according to patient and physician preference for RT. Based on 95% and 85% oncological treatment success for RT and PA, respectively, with a non-inferiority margin of 20%, at median 3 years of follow-up, PART requires 275 recruited men (137 per group, randomised on a 1:1 basis), for 80% power, with a one-sided alpha of 0.025. Allowing for a 10% total withdrawal or dropout rate, PART requires 306 recruited and randomised participants. CONCLUSIONS: The PART trial will provide robust prospective data and high-level randomised evidence to determine oncological treatment effectiveness of PA vs RT for localised irPCa, along with comparative side effect, HRQoL, and health economics evaluations, to inform clinical decision-making.

British Journal of Urology
NHS Lothian (GB), University College London Hospitals NHS Foundation Trust (GB), Imperial College Healthcare NHS Trust (GB), Barts Health NHS Trust (GB), Leeds Teaching Hospitals NHS Trust (GB), Western General Hospital (GB), Wexham Park Hospital (GB), University Hospitals Bristol NHS Foundation Trust (GB), Royal Berkshire Hospital (GB), Churchill Hospital (GB), Royal London Hospital (GB), Royal Berkshire NHS Foundation Trust (GB), Nuffield Orthopaedic Centre (GB), Charing Cross Hospital (GB), University Hospitals Coventry and Warwickshire NHS Trust (GB), East Kent Hospitals University NHS Foundation Trust (GB), John Radcliffe Hospital (GB), University of Bristol (GB), University of Oxford (GB), Museum of the History of Science (GB), Oxford University Hospitals NHS Trust (GB), University College London (GB), Imperial College London (GB)
Health Technology Assessment Programme
Good health and well-being
Openalex Percentile: Top 11%
Prostate Cancer Diagnosis and Treatment
DOIOpen Access PDFOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.