The PART study is a feasibility study comparing partial ablation (PA) and radical prostatectomy (RP) in men with intermediate risk unilateral prostate cancer. The aim of the feasibility is to determine whether or not it is possible to recruit and randomise men to a trial of this nature.
The PART Trial is a multicentre randomised controlled (RCT) trial funded by the NIHR HTA, and run out of SITU in Oxford. The Chief Investigator is Professor Freddie Hamdy, and the Trial Manager is Steffi le Conte.
The PART study aims to assess the clinical effectiveness and cost-utility of partial ablation (using HIFU) or radical prostatectomy in patients with intermediate risk, unilateral clinically localised prostate cancer. Phase 1 of the PART study aims to explore the methods and feasibility of data capture instruments.
Over decades, the principle of surgical ablation and/or radical treatment for cancer has evolved from total and extensive treatment of the affected organs to a more targeted and focal approach with, apparently, equal if not superior effectiveness, as well as fewer adverse events and improved quality of life. The concept is now evolving in prostate cancer using the promising but largely untested emerging technologies described above. Rather than radical therapy treating the whole gland, the aim is to localise and treat the main focus of cancer. An RCT is therefore needed to compare the effectiveness of this newer treatment, compared to the current gold standard treatment, radical prostatectomy.
- Men with unilateral clinically significant intermediate risk prostate cancer or dominant unilateral clinically significant intermediate risk & small contralateral low-risk disease:
- Gleason grade score 7 (3+4 or 4+3)
- High volume Gleason grade score 6 (> 4mm cancer core length)
- PSA ≤ 20 ng/ml
- ≤ T2b disease
- Life expectancy of ≥10 years
- Fit, eligible and normally destined for radical surgery
- No concomitant cancer
- No previous treatment of their prostate cancer
- An understanding of the English language sufficient to understand written and verbal information about the trial, its consent process and the study questionnaires
- Unfit for radical surgery
- Significant bilateral disease
- Low risk disease [Gleason score 6 or less, PSA 10ng/ml]
- High risk disease [Gleason score 8 or greater, PSA >20ng/ml]
- Men who have received previous active therapy for prostate cancer
- Men with evidence of extra prostate disease
- Men with an inability to tolerate a transrectal ultrasound
- Men with latex allergy
- Men who have undergone a Transurethral Resection of the Prostate (TURP) for symptomatic lower urinary tract symptoms within 6 months.
- Metal implants/stents in the urethra
- Prostatic calcification and cysts which interfere with effective delivery of HIFU
- Men with renal impairment and a GFR <35ml/min
- Unable to give consent to participate in the trial as judged by the attending clinicians