CHRONOS study

Comparative Health Research Outcomes of NOvel Surgery in prostate cancer (CHRONOS) 

Focal ablative therapy for localised clinically significant prostate cancer is an emerging treatment modality due to the improved post-procedural morbidity rates, and promising short-medium term cancer control outcomes. Though available on the NHS in limited centres, it is not readily available to all patients. The reason for this is the lack of high-quality trial-based evidence comparing focal therapies against radical whole gland treatments.

Attempts of randomised control trials have been unsuccessful, primarily due to lack of acceptance of randomisation treatment allocation, and lack of physician equipoise. The unique structure of CHRONOS using side by side RCTs allow patient preference and physician equipoise to be considered will ensure maximal recruitment and retention of eligible patients.

CHRONOS A

Will directly compare radical therapies to focal therapies, the aim of which is to directly assess both cancer control and functional outcomes of radical therapies to focal therapy. 

CHRONOS B

Will compare focal therapy, to focal therapy with neoadjuvant treatment, the aim of which is to improve the re-do rates observed in previous studies.

The embedded internal pilot objectives are:

• To determine patient acceptance to randomisation
• To conduct an embedded qualitative study of patient and clinician acceptance and experience of the linked RCT CHRONOS design
• To establish the feasibility of an economic evaluation alongside the main trial
• To determine acceptability and completeness of resource use and utility measures (EQ-5D-5L)
• To identify the relevant NHS and non-NHS resource use to be collected alongside the main trial
• To identify the relevant items to populate the Cost and Consequences framework
• To perform preliminary analysis of pattern of missing data. 
  

 Relevant publications

• Comparative Healthcare Research Outcomes of Novel Surgery in prostate cancer (IP4-CHRONOS): A prospective, multi-centre therapeutic phase II parallel Randomised Control Trial
• Feasibility of Comparative Health Research Outcome of Novel Surgery in prostate cancer (IP4-CHRONOS): statistical analysis plan for the randomised feasibility phase of the CHRONOS study