Clinical Trial

MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days

Study acronym: Proseven

Recruiting

Record status

This record was last updated December 4, 2024 (before its estimated February 2025 completion). Its status may not reflect the trial's current state.

Summary

The Proseven trial is a prospective interventional study that will evaluate the toxicity and efficacy of MR-guided stereotactic body radiotherapy (SBRT) in the profound hypofractionated treatment of prostate cancer. Patients will be treated in 5 daily fractions within a short overall treatment time (OTT) of 7 days. A simultaneous integrated boost (SIB) will be delivered to the intraprostatic dominant lesion (if present) in this study. Besides a potential biological impact of this innovative prostate SBRT treatment, the reduced OTT offers also benefits in terms of patient convenience. The primary endpoint is clinician reported grade 2 or more acute gastrointestinal (GI) and genitourinary (GU) toxicity, assessed using CTCAE v 5.0 and RTOG, measured up to 3 months after the first treatment fraction.

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2021-05-17; most recent amendment 2024-12-03.

Status change: Not Yet Recruiting → Recruiting 2021-08-10

Trial Details

NCT Number	NCT04896801
Lead Sponsor	Universitair Ziekenhuis Brussel
Conditions	Prostate Cancer
Enrollment	132 participants
Start Date	2021-08-10
Primary Completion	2025-02 (estimated)
Study Completion	2030-02 (estimated)
Updated on ClinicalTrials.gov	2024-12-04