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Table 1 Summary of treatment groups for the feasibility of IP4-CHRONOS-A and IP4-CHRONOS-B

From: 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

Treatment sequence Number of subjects Details
IP4-CHRONOS-A
 Control arm Feasibility, N=30 Radical radiotherapy or radical prostatectomy (as per physician and patient decision/preference)
 Intervention arm Feasibility, N=30 Focal therapy using HIFU or cryotherapy (as per physician and patient decision/preference)
 Total number Feasibility, N=60  
IP4-CHRONOS-B
 Control arm Feasibility, N=20 Focal therapy using HIFU or cryotherapy (as per physician and patient decision/preference)
 Intervention arm 1 Feasibility, N=20 Neoadjuvant finasteride 5mg once daily for a minimum of 12 weeks followed by focal therapy (as per standard care control arm for IP4-CHRONOS-B).
 Intervention arm 2 Feasibility, N=20 Bicalutamide 50mg once daily for 12 weeks followed by focal therapy (as per standard care control arm for IP4-CHRONOS-B)
 Total number Feasibility, N=60  
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Trials

ISSN: 1745-6215