Hypofractionated Whole-Pelvis Radiation Therapy (WPRT) vs Conventionally-Fractionated WPRT in Prostate Cancer

Official Title

Is Hypofractionated Whole-Pelvis Radiation Therapy (WPRT) as Well Tolerated as Conventionally-Fractionated WPRT in Prostate Cancer Patients? (HOPE-Trial)

Summary:

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

Trial Description

Primary Outcome:

• Quality of Life (QOL) - late bowel function as measured by the EPIC questionnaire

• Quality of Life - acute urinary and sexual QOL as measured by the EPIC questionnaire
• Quality of Life - acute bowel toxicity as measured by the EPIC questionnaire
• Quality of Life - late bowel bother as measured by the EPIC questionnaire
• Quality of Life - late urinary and sexual QOL as measured by the EPIC questionnaire
• International Prostate Symptom Score (IPSS)
• Toxicity - urinary, bowel, and sexual as measured by CTCAE version 4.0
• Prostatic Specific Antigen (PSA) curve
• Prostatic Specific Antigen (PSA) Nadir
• Cost Effectiveness of Hypofractionated WPRT
• Overall Survival
• Biochemical Failure-Free Survival
• Freedom from Local Failure
• Freedom from Regional Failure
• Androgen Deprivation Therapy Free Survival
• Metastasis Free Survival
• Prostate Cancer Free Survival

View this trial on ClinicalTrials.gov