A phase III study comparing partial prostate ablation versus radical prostatectomy (PART) in intermediate risk prostate cancer - initial data from the feasibility study
BAUS ePoster online library. Leslie T.
Jun 26, 2018; 211344
Mr. Tom Leslie
Mr. Tom Leslie
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Background: Men with intermediate-risk, localised prostate cancer (PCa) are offered radical treatments (RT) such as radical prostatectomy (RP), which can cause significant side-effects. Alternatively, partial ablation (PA) technologies are now available, which may reduce treatment burden. RT versus PA has never been evaluated in a randomised clinical trial(RCT).

Objective: To assess feasibility of a RCT of PA versus RT for intermediate risk PCa.

Design: A prospective, multi-centre, feasibility study was conducted to inform the design and conduct of a future RCT, involving a QuinteT Recruitment Intervention (QRI) to understand barriers to participation.

Participants: Men with unilateral, intermediate-risk, clinically localised PCa offered randomisation to PA (in the form of HIFU) or RP.

Results: 82 men were randomised (41 to RP, 41 to PA). The QRI study was key in identifying recruitment barriers, and enabled development of tailored strategies to optimise recruitment, which increased from 1.4 patients/month to 4.5 patients/month. The most common reason for declining randomisation was treatment preference. 51(22%) of eligible patients declining randomisation chose RP, 27(11%) active surveillance, 26(11%) PA, and 21(9%) radiotherapy. EuroQol EQ-5D-5L utility scores were limited by small numbers, but highlight potential health gains for patients receiving PA compared to RP. HRQoL outcomes relating to urinary and sexual function were better in the PA than RP group, but no significant differences were observed in overall HRQoL between groups.

Conclusions: Randomisation of men to a RCT comparing PA and radical treatment for intermediate risk PCa is feasible. A full RCT of PA versus RT is now warranted.

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