Data from clinicaltrials.gov - Curated by EPG Health - Last updated 10 January 2020

The purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is...

purpose

The purpose of this research study is to determine if 5 (five) fractions of external radiotherapy with higher radiation doses per fraction to the pelvis leads to similar results to the standard of care external radiotherapy treatment that is comprised of 25 fractions of external radiotherapy with lower radiation doses per fraction to the pelvis.

This study aims to investigate the impact in quality of life associated with hypofractionated Whole Pelvis Radiotherapy (WPRT) in comparison to conventionally-fractionated WPRT in patients with unfavorable-intermediate and high-risk prostate cancers. This information is valuable as hypofractionated WPRT is a more attractive and convenient treatment approach, and may become the new standard of care if proven to be well-tolerated and effective. Therefore, this study aims to provide a more rational justification for use of hypofractionated WPRT in future larger randomized trials by comparing this strategy with the current standard of care. This study will also provide an initial understanding of the toxicity profile and cancer control associated with hypofractionated WPRT and High Dose Rate Brachytherapy (HDR-BT).


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Is Hypofractionated Whole-Pelvis Radiotherapy (WPRT) as Well Tolerated as Conventionally-Fractionated WPRT in Prostate Cancer Patients? (HOPE-Trial)
Estimated Study Start Date: January 2020
Estimated Primary Completion Date: March 2023
Estimated Study Completion Date: March 2027

Arms:
- Active Comparator:
Conventionally-fractionated WPRT
- Experimental: Hypofractionated WPRT

Category Value
Date last updated at source 12-Dec-19
Study type(s) Interventional
Expected enrolment 58
Study start date 01-Jan-20
Estimated primary completion date 01-Mar-23

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