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

Prostate cancer is the most common cancer in UK men. Some men have cancer on one side of the prostate, but are still offered treatment to the whole prostate. New technologies can now treat part of the prostate only, destroying the cancer but preserving urinary and sexual functions. These technologies may have fewer side-effects, but none has been compared with radical treatments to ensure they are as safe and effective. One such technology is Vascular Targeted Photodynamic Therapy (VTP), which has shown promising results in men with low-risk prostate cancer compared to no treatment. VTP involves giving an injection to make prostate cells sensitive to light. Small fibres are then placed into the prostate under anaesthetic, through the skin between the scrotum and anus (perineum). A laser is then shone down the fibres into the prostate. We have evidence that this destroys cancer cells, and may lead to fewer side-effects than radical treatment. VTP side-effects may include irritation to the urinary system, a small chance of sexual side effects and mild discomfort. We now want to test VTP in men with higher (intermediate) risk prostate cancer who would usually be advised to have radical treatment.

Background

Prostate cancer (PCa) is the most common cancer in UK men. 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

To assess the clinical and cost-effectiveness of PA using one of the foremost technologies: Vascular Targeted Photodynamic Therapy (VTP) versus the standard radical treatments currently available on the NHS (i.e. radical prostatectomy [RP], radical radiotherapy [RRT] and low dose-rate brachytherapy [LDR-B]) for unilateral intermediate-risk PCa; and to provide high-quality evidence on the comparative benefits and risks of these treatment options in terms of oncological outcome and quality of life (QoL).

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. 800 men with intermediate-risk unilateral clinically localised PCa will be randomised to radical treatment or PA using VTP. Follow-up will be conducted using standard NHS care protocols for the radical treatment group, and a combination of multi-parametric Magnetic Resonance Imaging (mpMRI) and repeat targeted or systematic prostate biopsies in the PA group.

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).