Contact information
Type
Public
Primary contact
Dr Kate Belaya
ORCID ID
http://orcid.org/0000-0002-0718-4987
Contact details
Nuffield Department of Surgical Sciences
University of Oxford
Old Road Campus Research Building
Roosevelt Drive
Oxford
OX3 7DQ
Oxford
OX3 7DQ
United Kingdom
+44(0)1865 617 124
katsiaryna.belaya@nds.ox.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov 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
Acronym
PART
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Prostate cancer
Intervention
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
Mixed
Phase
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
28/02/2019
Overall trial end date
01/04/2026
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Male
Target number of participants
800
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
01/10/2019
Recruitment end date
30/09/2024
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
University of Oxford
Sponsor details
Clinical Trials and Research Governance (University of Oxford)
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7LQ
Oxford
OX3 7LQ
United Kingdom
+44(0)1865 289885
ctrg@admin.ox.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
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.
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/04/2026
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list