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

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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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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