Partial prostate Ablation versus Radical prosTatectomy (PART)
Research type
Research Study
Full title
A randomised controlled trial of Partial prostate Ablation versus Radical prosTatectomy (PART) in intermediate risk unilateral clinically localised prostate cancer.
IRAS ID
159568
Contact name
Freddie Hamdy
Contact email
Duration of Study in the UK
5 years, 0 months, days
Research summary
Prostate cancer has become the most common cancer in men, accounting for nearly 13% of male deaths from cancer in the UK and is the second most common cause of male cancer deaths, after lung cancer. Despite its high incidence and social and economic impact, prostate cancer continues to be under researched. In general, the conventional treatments are radical prostatectomy (RP), radiation therapy and active monitoring/surveillance. The ProtecT study (conducted by the applicants) is currently comparing the effectiveness of these 3 treatments and the primary outcome analysis will be performed in 2015. ProtecT will provide key information about the effeteness of conventional treatments, but has not been testing focal therapy, which forms the basis of the PART study.
As radical treatments carry the potential for significant short, medium and long-term morbidity such as urinary leakage, erectile dysfunction and radiotherapy toxicity, there has been interest in developing alternative ablative therapies in an attempt to reduce treatment burden whilst retaining cancer control, and to avoid the psychological morbidity associated with surveillance. Techniques include HIFU, cryotherapy, VTP, radiofrequency interstitial tissue ablation (RITA), laser photocoagulation and irreversible electroporation. However, as yet, these minimally invasive technique have not been evaluated sufficiently to reliably inform their utilisation within the NHS.
PART aims to compare ablative therapy (using HIFU) with radical prostatectomy in men with intermediate risk prostate cancer. This is the first phase III study comparing these treatments to assess clinical effectiveness and cost-utility.
The PART study will be conducted in two phases: a feasibility phase followed by the main recruitment phase. It is hoped the first phase of the PART study will show that it is feasible, and acceptable to the relevant patients, to carry out a larger RCT of partial ablation versus radical prostatectomy for intermediate risk, unilateral prostate cancer.
Currently, funding is only available for Phase 1 of the study. Our aim is to apply for additional funding for Phase 2, once the feasibility of the PART study has been established.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
14/SC/1376
Date of REC Opinion
1 Dec 2014
REC opinion
Favourable Opinion