NCT04612907

Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

A Randomized Phase III, Multicenter Study to Evaluate Different Fractionation Schedules of Radiotherapy to the Primary Tumour in Metastatic Hormone Sensitive Prostate Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

de Novo metastatic prostate cancer with limited metastatic spread benefits from local radiotherapy to the prostate. Two different fractionation schedules will be tested.

Detailed description

Patients with de Novo metastatic prostate cancer with limited disease spread has been shown to gain benefit from local radiotherapy to the prostate. The internationally accepted fractionation schedule is 3 Gy (Gray) x 19-20 over a course of 4 weeks. There is continous evidence for even more hypo-fractionated radiotherapy with higher fractionation doses. We will test if the schedule of 6.1Gy x 6 compares to standard of 3 Gy x 19 with regard to patient reported side-effects.

Conditions

• Prostate Cancer
• Radiotherapy Side Effect
• Metastatic Cancer

Interventions

Type	Name	Description
RADIATION	Moderate hypo-fractionation	Patients will receive four weeks of radiotherapy
RADIATION	Ultra-hypo-fractionation	Patients will receive two and a half weeks of radiotherapy

Timeline

• Start date: 2022-10-31
• Primary completion: 2026-06-30
• Completion: 2032-09-30
• First posted: 2020-11-03
• Last updated: 2024-02-28

Locations

1 site across 1 country: Sweden