PART
Research type
Research Study
Full title
PART: A randomised controlled trial of Partial prostate Ablation versus Radical Treatment in intermediate risk, unilateral clinically localised prostate cancer
IRAS ID
315065
Contact name
Richard Bryant
Contact email
Sponsor organisation
University of Oxford /Research Governance, Ethics & Assurance Team (RGEA)
Eudract number
2019-003669-16
ISRCTN Number
ISRCTN17249875
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
The PART study aims to test whether treating only the part of the prostate containing the prostate cancer is as effective in curing prostate cancer as treating the whole prostate gland) and has fewer side effects. Treatment of the whole prostate gland (known as ‘radical’ treatment) includes surgical removal, radiotherapy, or brachytherapy.
Prostate cancer is the most common cancer in men in the UK. Treatment of the whole prostate (‘radical’ treatment) is normally offered, even if the cancer is only on one side of the prostate gland. New technologies can now treat the part of the prostate affected by the cancer only (known as ‘partial ablation’, or PA), destroying the cancer but preserving urinary and sexual functions. PA shows promising results in terms of having minimal side effects in men with low-risk prostate cancer, compared to a policy of ‘active surveillance’ (i.e. no active treatment). We want to test PA in men with intermediate-risk localised prostate cancer, who would usually be advised to have radical treatment.
The two types of PA in this trial will be Irreversible Electroporation (IRE) and High Intensity Focal Ultrasound (HIFU). IRE is an image-guided tissue ablation technology that induces cell death via short, strong pulsed electric fields. Due to its non-thermal nature, IRE preserves vessels, nerves and extracellular matrix, making it an effective treatment modality for prostate cancer. HIFU uses ultrasound energy focused by an acoustic lens to cause tissue damage as a result of thermal coagulative necrosis and acoustic cavitation. HIFU is available in a number of centres in the UK and is approved by the NHS as a treatment for pancreatic and liver cancer.
We aim to recruit 800 men from 10+ hospitals in the UK. Participants will be randomly allocated to either radical treatment (choice of surgery or radiotherapy or brachytherapy, as most appropriate) or PA treatment (IRE or HIFU). All patients will be assessed regularly to check if the treatments have worked, using blood tests and (for the PA arm) repeat imaging and prostate biopsies. If there is any sign of the disease returning or worsening, additional treatments will be discussed and offered. We will compare how well the treatments work by measuring the time it takes for additional treatment to be necessary in the radical treatment arm, or to require treatment of the whole prostate gland, or other prostate cancer-specific treatment, in the PA arm. We will also assess quality of life using questionnaires, and costs to the NHS of each treatment.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
23/SC/0012
Date of REC Opinion
17 Jan 2023
REC opinion
Favourable Opinion