Condition category
Cancer
Date applied
28/02/2019
Date assigned
04/03/2019
Last edited
05/08/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Plain English summary under review with external organisation

Trial website

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

https://researchsupport.admin.ox.ac.uk/ctrg

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

Publication citations

Additional files

Editorial Notes

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.