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

Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer

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.

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

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