Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Plain English summary under review with external organisation

Trial website

Contact information



Primary contact

Ms Emma Harper


Contact details

Surgical Intervention Trials Unit (SITU)
Nuffield Department of Surgical Sciences
University of Oxford
Botnar Research Centre
Nuffield Orthopaedic Centre
Windmill Road
United Kingdom
+44 01865 227176

Additional identifiers

EudraCT number

Nil known number

Nil known

Protocol/serial number

HTA 17/150/01

Study information

Scientific title

A randomised controlled trial of Partial prostate Ablation versus Radical Treatment (PART) in intermediate risk, unilateral clinically localised prostate cancer



Study hypothesis

Partial ablation (PA) for unilateral intermediate-risk prostate cancer is a safe and effective alternative to radical treatment, with improved quality of life, but without unduly compromising oncological outcomes. More specifically, we hypothesise that:
1. Organ-preserving treatment with PA offers comparable benefit to radical treatment in prostate cancer control
2. The side-effect profile of PA is favourable compared with radical treatment
3. The ‘trade-off’ between health-related quality of life (HRQoL) and oncological outcomes for men with localised prostate cancer favours partial ablation compared with radical treatment

Ethics approval

We will apply for the Ethics Approval at a later date.

Study design

Multicentre, interventional, open label, randomised controlled trial.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

No participant information sheet available


Prostate cancer


Intervention arm: partial ablation of the prostate.

Comparator arm: one of standard NHS radical treatment options:
1. Radical prostatectomy
2. Radical radiotherapy
3. Low dose-rate brachytherapy

800 patients will be randomised equally between either partial ablation or radical treatment.

The follow-up for all treatment options will be 3 years.

Intervention type



Drug names

Primary outcome measure

1. Oncological outcomes assessed by review of medical history at 3 years median follow-up post-randomisation
2. Side effects profile and patient-reported outcomes assessed by review of medical history and questionnaires at 3 years median follow-up post-randomisation

Secondary outcome measures

1. Quality of life assessed using validated questionnaires at 6 weeks, 3 months, 6 months, 12 months, 24 months and 36 months post-treatment
2. Health resource utilisation assessed using validated questionnaires at 6 weeks, 3 months, 6 months, 12 months, 24 months and 36 months post-treatment
3. Short, medium and long-term effects assessed through review of medical history at 30 days (short term) and 3 years (medium term). We will apply for longer-term follow-up at the end of the main stage of the trial.
4. Proportion of patients needing repeat treatment in the partial ablation group, assessed by review of medical history at 1 year and 3 years
5. Accuracy of mpMRI imaging and biopsy protocols in determining suitability of patients for partial ablation, assessed using review of medical history and histopathological data at 6 weeks post-treatment
6. Longer-term disease-specific and overall mortality assessed using long-term follow-up using national registries

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Unilateral clinically significant intermediate-risk prostate cancer, or dominant unilateral clinically significant intermediate-risk prostate cancer and small contralateral low-risk low-volume prostate cancer:
1.1. Grade Group 2 or 3 (Gleason Grade 3+4 or 4+3) disease
1.2. And/or >4 mm cancer core length in any one core irrespective of Grade Group
1.3. PSA ≤20 ng/ml
1.4. Clinically ≤T2b disease judged by results of digital rectal examination and imaging by mpMRI
2. Prostate volume <70 cm3 and ≥25 cm3
3. Fit, eligible with standard of care recommendation for RP, RRT or LDR-B
4. Life expectancy of ≥10 years
5. No concomitant cancer and no previous active treatment for prostate cancer
6. Pre-biopsy mpMRI scan and biopsy (transrectal targeted guided by presence of PIRADS lesions +/- systematic biopsy, or template transperineal mapping biopsy)
7. Understanding of the English language sufficient to receive written and verbal information about the trial, its consent process and complete study questionnaires

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Unfit for radical treatment or general anaesthesia, or cannot tolerate transrectal ultrasound
2. Bilateral Intermediate risk disease or higher
3. Low-risk disease (Grade Group 1, PSA ≤10 ng/ml, <4 mm total cancer on biopsy) or high-risk disease (Grade Group ≥4, PSA >20 ng/ml, ≥T2c stage)
4. Clinical T3 prostate cancer (i.e. extra-capsular prostate cancer) on digital rectal examination or mpMRI, or evidence of metastatic disease
5. Prostate volume ≥70 cm3 or <25 cm3
6. Previous active therapy for prostate cancer
7. History of sun hypersensitivity or photosensitive dermatitis or latex allergy
8. History of acute urinary retention within 6 months of study entry or who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms, or with metal implants/stents in the urethra, or with a history of a urethral stricture
9. Conditions requiring medication with potential photosensitizing effects (tetracyclines, quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin, and amiodarone), if these treatments could not be stopped at least 10 days before and for 3 days after the partial ablation procedure or replaced by treatments without photosensitizing properties
10. Anticoagulant drugs (e.g., warfarin) that could not be withdrawn during the 10 days prior to the partial ablation procedure or antiplatelet drugs (e.g. aspirin) that could not be withdrawn during the 10 days prior to the partial ablation procedure and 3 days after the partial ablation procedure
11. Prostatic calcification and cysts that interfere with the effective delivery of partial ablation
12. Renal impairment and/or a Glomerular Filtration Rate (GFR) <35 ml/min
13. Men unable to give consent to participate in the trial as judged by the clinical staff

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
United Kingdom

Sponsor information


University of Oxford

Sponsor details

Clinical Trials and Research Governance (University of Oxford)
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
United Kingdom
+44(0)1865 289885

Sponsor type




Funder type


Funder name

National Institute for Health Research

Alternative name(s)


Funding Body Type

government organisation

Funding Body Subtype

National government


United Kingdom

Results and Publications

Publication and dissemination plan

Results will be disseminated in the form of presentations at national and international learned societies and published in abstracts and full manuscripts in peer-reviewed journals after the overall trial end.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date


Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/04/2020: A public contact was removed. 28/11/2019: Contact details updated, the recruitment start date was changed from 01/10/2019 to 01/03/2020. 05/08/2019: Internal review. 21/06/2019: Internal review. 05/04/2019: Internal review. 22/03/2019: The condition has been changed from “Specialty: Cancer, Primary sub-specialty: Prostate Cancer; UKCRC code/ Disease: Cancer/ Malignant neoplasms of male genital organs” to “Prostate cancer” following a request from the NIHR. 05/03/2019: Internal review. 28/02/2019: Trial's existence confirmed by the NIHR.