Clinical Research Directory

Prostate Radiotherapy Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)

Sponsor: Tata Memorial Centre

Summary

Aim: The aim of the study is to compare the efficacy with SBRT and moderate hypo-fractionation in high risk and node positive prostate cancer PRIMARY STUDY OBJECTIVES: To assess whether extreme hypo-fractionation with SBRT in high risk prostate cancer is non inferior to moderately hypo-fractionated standard radiotherapy STUDY DESIGN: Two arm, Prospective Randomized Trial with a non-inferiority design TREATMENT REGIMEN: Arm 1-\[standard arm\] Moderate hypo-fractionated RT, total dose of 66-68 Gray(Gy) in 25# to the primary over 5 weeks, with treatment being delivered daily. All patients irrespective of nodal status will receive a dose of 50 Gy in 25# to the pelvic nodes.Boost to gross nodal disease will be considered based on the response to hormonal therapy to a dose of 60-66 Gy/25# as a simultaneous integrated boost (SIB). An option of equivalent biological dose using 60-62.5 Gy in 20# may be allowed for multi-centric accrual in the future. Arm 2 -\[Experimental Arm\] Extreme hypo-fractionation with SBRT,course of 5 fractions of radiation; each of size 7-7.25 Gy. The total dose will be 35-36.5 Gy. All patients irrespective of nodal status will receive a dose of 25 Gy in 5 # to the pelvic nodes. The 5 treatments will be scheduled to be delivered alternate day over approximately 7-10 days. An option of equivalent biological dose using 35-36.5 Gy in 5 weekly fractions may be allowed for multicentric accrual in the future. RECRUITMENT TARGET: 464 total (232 patients experimental arm and 232 patients standard arm) recruitment over 6 years, with a non-fixed follow up period and a uniform accrual rate. PRIMARY ENDPOINT To assess the 5 year Biochemical Failure free Survival (BFFS) between the two arms. Follow-up At 3-6 weeks from end of radiotherapy, followed by 3-6 monthly for the first two years and 6 monthly thereafter.

Official title: Randomised Controlled Trial of Prostate Radiotherapy In High Risk and Node Positive Disease Comparing Moderate and Extreme Hypo-fractionation (PRIME Trial)

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