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
270336
Contact name
Freddie Hamdy
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Eudract number
2019-003669-16
ISRCTN Number
ISRCTN17249875
Duration of Study in the UK
5 years, 6 months, 31 days
Research summary
Research 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, radiotherapy or brachytherapy (known as ‘radical’ treatments).
Prostate cancer is the most common cancer in UK men. Treatment of the whole prostate is offered, even if the cancer is on one side of the prostate only. New technologies can now treat part of the prostate only, destroying the cancer but preserving urinary and sexual functions. One such technology, Vascular Targeted Photodynamic Therapy (VTP) has shown promising results in men with low-risk prostate cancer compared to no treatment. We want to test VTP in men with intermediate-risk prostate cancer who would usually be advised to have radical treatment.
VTP involves injection of a light-sensitive drug, small fibres are then placed into the prostate under anaesthetic and a laser is shone down the fibres. Side effects may include irritation to the urinary system, a small chance of sexual side effects and mild discomfort.
We aim to recruit 800 men from 15 UK centres. Participants will be randomly allocated to either radical treatment (choice of surgery or radiotherapy) or partial treatment (VTP). All patients will be assessed regularly to check if the treatments have worked, using blood tests and (for the partial treatment arm) repeat imaging and 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 in the partial treatment arm. We will also assess quality of life using questionnaires, and costs to the NHS of each treatment.Summary of Results
This trial was previously given REC and HRA approval under IRAS 270336. It was a clinical trials of investigational medicinal product (CTIMP) which needed to report safety events to the Medicines and Healthcare products Regulatory Agency MHRA. The trial changed one of the treatments it was using, which meant it had to be closed down before opening. The study is now open for more information. https://part-trial.octru.ox.ac.uk/
REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0070
Date of REC Opinion
12 Mar 2021
REC opinion
Favourable Opinion