Spots Global Cancer Trial Database for MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
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Trial Identification
Brief Title: MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Official Title: Prospective Study of MR-guided Prostate Stereotactic Body Radiotherapy in Seven Days
Study ID: NCT04896801
Conditions
Interventions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel, Brussels, , Belgium
Contact Details
Name: Mark De Ridder, MD
Affiliation: Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Role: PRINCIPAL_INVESTIGATOR
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