Introduction

Recent findings from the ProtecT trial suggest that survival in clinically localised prostate cancer is very high, and that radical treatments half the incidence of metastatic disease progression but at the cost of significant side effects. Using minimally invasive technology, such as HIFU or cryotherapy, for partial gland ablation (PA) could reduce these side effects. _x000D_ _x000D_ Partial prostate Ablation versus Radical prostatectomy (PART trial) is the first phase III study to compare PA and radical surgery (RP) in intermediate risk prostate cancer. PART is a prospective, multi-centre, parallel group randomised controlled trial to assess the clinical effectiveness and cost-utility of PA or RP in patients with intermediate risk, unilateral clinically significant localised prostate cancer. Our hypothesis is that PA of the prostate using minimally invasive therapies can achieve organ preservation, reduce side effects, maintain good voiding and sexual function, without compromise to oncological outcomes. We report the outcomes of our successful feasibility study which will now drive the establishment of the main multi-centre randomised controlled trial. _x000D_

Methods

Participants were eligible when diagnosed with intermediate risk, unilateral clinically significant localised prostate cancer, fit for either RP or PA. Pre-biopsy mpMRI and targeted biopsy or template guided biopsies were compulsory before randomization to either RP or PA. Target accrual for the feasibility phase was 80 patients over 18 months. Follow-up involved regular PSA measurements and, in the focal therapy arm, mpMRI and targeted biopsies of any suspicious areas. Quality of life data were measured at six weeks and three monthly intervals.

Results

The table below summarises recruitment data. Baseline demographics of men randomised to date are Mean age: 66.7yrs (48.4-78.2); BMI: 26.4 (22.0-32.3); PSA: 7.60 (2.5-16.20) and Gleason score: 3+4=7 75.6%, 4+3=7 24.4%._x000D_

Conclusions

A randomised controlled trial of partial ablation of the prostate versus radical treatment with surgery is feasible. The full trial is being developed, and will provide key data to inform men when making the treatment decision for intermediate risk unilateral prostate cancer.

Funding

None