A randomised controlled trial of Partial prostate Ablation versus Radical Treatment in intermediate risk, unilateral clinically localised prostate cancer (PART)
The PART study will directly compare Partial Ablation with Radical Treatments for intermediate-risk prostate cancer on one side of the prostate. Partial Ablation aims to destroy (ablate) all the cancer cells in one side of the prostate gland using techniques that are less invasive including High Intensity Ultrasound (HIFU) or Irreversible Electroporation (IRE) (where quick electrical pulses are administered, with the use of electrodes, around and into the tumour to kill cancerous cells) . Radical Treatments are surgery (prostatectomy), radiotherapy or a form of radiation therapy where a sealed radiation source is placed inside or next to the area requiring treatment (brachytherapy). They are called ‘Radical Treatments’ because they aim to remove or destroy all the cancer cells that might be present in the whole prostate gland, so that they cannot grow or spread.
Background
Prostate cancer is the most common cancer in men. Many prostate cancers are confined within the prostate gland (‘localised’) and grow very slowly. These are labelled ‘low-risk’ because they are unlikely to grow fast enough, or spread elsewhere, to cause any harm in a man’s lifetime. Cancers that are more likely to grow quickly and spread outside the prostate gland are called ‘high-risk’. Intermediate-risk cancers are in between high- and low-risk – they have some potential to grow and spread but are unlikely to do so for a few years or longer. Patients with intermediate-risk, clinically localised disease are offered radical treatments such as surgery or radiotherapy, which achieve good disease control but can result in urinary, bowel, and sexual side effects. Alternative partial ablation (PA) technologies are being introduced that have fewer such side effects, however, their effectiveness compared to radical treatments has not been evaluated rigorously. The applicants have completed a feasibility study [HTA - 12/35/54] and now propose to undertake a full randomised controlled trial (RCT).
Aims and Objectives
The aim of the PART study is to determine whether partial ablation for unilateral intermediate-risk prostate cancer provides effective oncological outcomes compared with radical treatment, with the added benefits of reduced side effects, and an improved patient reported outcomes profile.
The primary objectives are:
1) To determine whether partial ablation provides effective oncological outcomes compared with radical treatment
2) To determine whether partial ablation has a reduced side effect profile, and an improved patient-reported outcomes profile, compared with radical treatment
Study Design
A prospective, multi-centre RCT incorporating an integrated QuinteT Recruitment Intervention (QRI) to understand, monitor and address barriers to participation. The setting will be 10 or more large Urology departments in NHS hospitals. PART aims to recruit 800 men with intermediate-risk unilateral clinically localised PCa will be randomised to radical treatment or PA.
Summary
The PART Trial aims to test whether partial treatment of the prostate is as effective in curing prostate cancer (and has fewer side effects) as treatment of the whole prostate by surgical removal or radiotherapy (known as ‘radical’ treatments).
