MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)
NCT ID: NCT03880851
Last Updated: 2019-03-20
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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UNKNOWN
NA
78 participants
INTERVENTIONAL
2019-01-23
2024-01-31
Brief Summary
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Detailed Description
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Personalized adaption of treatment plan dependning on volume-/ and constraint-thresholds and evaluation of biomarkers (multiparametric MRI, blood, tissue, stool, urine).
Treatment at MR-Linac allowed
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hypofractionated image-guided radiotherapy
Hypofractionated image-guided radiotherapy "IGRT" to a total dose of 60 Gy (20 fractions) is performed.
Weekly MRI are used to estimate volume/deformation changes of OAR and target volume.
Intervention: In case of a significant change of target volume or OARs (threshold based) the radiation treatment plan is adapted on individual MR-anatomy.
Plan adaptation of Radiation Treatment in case of anatomical changes
Image guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes.
Interventions
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Plan adaptation of Radiation Treatment in case of anatomical changes
Image guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes.
Eligibility Criteria
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Inclusion Criteria
* cT1b-cT3a cN0 cM0
* ECOG Performance score 0-2
* IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)
* age\>18 years
* Informed consent
* contraindication against curative RT
* age\<18 years
* previous pelvic radiotherapy or planned pelvic radiotherapy
* comorbidities interfering with image-guided radiotherapy
* contraindications against multiparametric MRI (like hio prosthesis, pacer, allergy against contrast media)
* prior transurethral resection, highly focussed ultrasound or other pre-treatment of prostate
18 Years
MALE
Yes
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Arndt-Christian Mueller
Deputy Head of the Department of Radiation Oncology
Locations
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Müller Arndt-Christian
Tübingen, , Germany
Countries
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Central Contacts
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Arndt-Christian Müller
Role: CONTACT
Facility Contacts
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Other Identifiers
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Mbase HyPro 2.0
Identifier Type: -
Identifier Source: org_study_id
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