MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0) (Mbase_HyPro)

U

University Hospital Tuebingen

Status

Enrolling

Conditions

Prostate Cancer

Treatments

Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes

Study type

Interventional

Funder types

Other

Identifiers

NCT03880851
Mbase HyPro 2.0

Details and patient eligibility

About

Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.

Full description

IGRT-schedule: 20 fractions to a total dose of 60 Gy 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

Enrollment

78 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • biopsy-proven prostate cancer with indication for RT
  • 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

Exclusion criteria

  • not fulfilled inclusion criteria
  • 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

Trial design

78 participants in 1 patient group

Hypofractionated image-guided radiotherapy
Other group
Description:
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.
Treatment:
Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes

Trial contacts and locations

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Central trial contact

Arndt-Christian Müller; Silke Theden

Data sourced from clinicaltrials.gov

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