Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer

The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are: \- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects? Participants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.

NCT Number	NCT06518226
Lead Sponsor	UMC Utrecht
Conditions	Prostate Cancer, Prostate Adenocarcinoma, Localized Prostate Carcinoma
Enrollment	160 participants
Start Date	2024-03-28
Primary Completion	2026-07-01 (estimated)
Study Completion	2031-02-01 (estimated)
Updated on ClinicalTrials.gov	2024-07-24