Addition of a Focal Boost in External Beam Radiotherapy for Locally Advanced Prostate Cancer by Online Adaptive MR-guided Radiotherapy
NCT ID: NCT05373316
Last Updated: 2022-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
95 participants
INTERVENTIONAL
2022-12-01
2029-07-01
Brief Summary
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This focal boost strategy is now proven for a conventional fractionation scheme (35 fractions). The current trend in radiotherapy for prostate cancer is (extreme) hypofractionation, reducing the number of fractions. For locally advanced prostate cancer, however, the data on extreme hypofractionation are scarce.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MR-guided hypofractionated focal boost radiotherapy
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MR
Ultrahypofractionated MR-guided radiotherapy boost
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MRI.
Interventions
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Ultrahypofractionated MR-guided radiotherapy boost
External beam MR-guided (MR-linac) radiotherapy to the prostate and seminal vesicles of 5x7Gy (once weekly) with an isotoxic integrated focal boost up to 50Gy to the intraprostatic tumor as visible on multiparametric MRI.
Eligibility Criteria
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Inclusion Criteria
* Imaging stage T3b (as defined on mpMRI) N0M0
* Intraprostatic lesion visible on MRI
* Capable of giving informed consent
Exclusion Criteria
* Contraindications for MRI according to the guidelines of the local department of Radiology, inability to lay on a treatment table for 45-60 minutes or severe claustrophobia
* Absence of pre-treatment PSMA PET CT
* WHO performance score \> 2
* International Prostate Symptom Score ≥ 15
* PSA \> 30
* Prostate volume \>100c
18 Years
100 Years
MALE
No
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Locations
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Radboudumc
Nijmegen, Gelderland, Netherlands
Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL79869.091.22
Identifier Type: -
Identifier Source: org_study_id
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