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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