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MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Sponsor: Universitair Ziekenhuis Brussel
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.
Official title: Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2021-08-10
Completion Date
2030-02
Last Updated
2024-12-04
Healthy Volunteers
No
Conditions
Interventions
MR-guided RT
The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy \< 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT
Locations (1)
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Brussels, Belgium