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

NCT03561961 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 526

Last updated 2025-02-13

No results posted yet for this study

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.

Conditions

  • Prostate Adenocarcinoma

Interventions

RADIATION

Moderate Hypo-fractionation

66-68Gy in 25#

RADIATION

Extreme Hypo-fractionation

35-36.25 Gy in 5#

Sponsors & Collaborators

  • Tata Medical Center

    collaborator OTHER

  • Tata Memorial Centre

    lead OTHER

Principal Investigators

  • Vedang Murthy · Tata Memorial Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-24
Primary Completion
2024-09-27
Completion
2035-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03561961 on ClinicalTrials.gov