Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06518226
NA

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

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

Summary

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.

Official title: Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2024-03-28

Completion Date

2031-02-01

Last Updated

2024-07-24

Healthy Volunteers

No

Interventions

RADIATION

Ultrahypofractionated MRgRT in 2 fractions

2x12 Gy with boost to GTV up to 13.5 Gy

RADIATION

Standard of care: MRgRT in 5 fractions

5x7.25 Gy

Locations (1)

University Medical Center Utrecht

Utrecht, Netherlands