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Clinical Trial Summary

The Proseven trial is a phase II 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04896801
Study type Interventional
Source Universitair Ziekenhuis Brussel
Contact Benedikt Engels, MD
Phone 00324776041
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date July 2021
Completion date July 2029

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