Protons vs. Photons for High-risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Lymph Node Radiation Therapy With Integrated Boost to Prostate for High-risk Prostate Cancer A Randomized Phase 3 Trial Comparing Photons vs. Protons

Status Recruiting

Clinical Trial Summary

The purpose of this study is to assess late gastro-intestinal side-effects comparing proton therapy to photon therapy in high-risk prostate cancer patients receiving whole pelvic irradiation.

Clinical Trial Description

Proton therapy (PT) is a radiation technique with possibility to spare normal pelvic organs: bladder, rectum and bowel for PC patients. Most PC patients treated with PT receive PT to the prostate gland alone. With PT, we aim to examine PC patients in high risk with both lymph node and prostate treatment will experience less late side effects with PT compared to photon treatment. The investigators propose a national open-labelled phase III randomized controlled trial (RCT) of proton therapy versus photon therapy of the prostate including the regional elective LN for localized/locally advanced prostate cancer patients combined with androgen deprivation therapy (ADT) aimed at 3 years. The investigators aim at reducing gastro-intestinal toxicity grad 2 more than 5 points, which is considered clinical significant, measured by mean Expanded Prostate Cancer Index Composite-26 (EPIC-26) bowel scores at 24 months and improve HRQOL. Secondary endpoints include morbidity, quality of life and survival data up to 10 years after treatment. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy Side Effect

• NCT number: NCT05350475
• Study type: Interventional
• Source: University of Aarhus
• Contact: Lise Bentzen
• Phone: +45 78 45 64 00
• Email: lise.b@rm.dk
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Completion date: March 1, 2037