Clinical trial NCT03880851: MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)
Official title: Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Keywords: hypofractionation
MR-based IGRT
Mbase HyPro
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 78
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2
timeFrame: 2 years
Secondary outcomes:
measure: Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT
timeFrame: 6 months
measure: Rate of participants achieving local control
timeFrame: 2, 5, 10 years
measure: Rate of participants achieving regional control
timeFrame: 2, 5, 10 years
measure: Rate of participants achieving Distant-metastasis-free survival "DMFS"
timeFrame: 2, 5, 10 years
measure: Number of Participants with biochemical no evidence of disease "bNED"
timeFrame: 2, 5, 10 years
measure: Time without secondary treatment "TWIST"
timeFrame: 2, 5, 10 years
measure: CTC-Proctitis
timeFrame: 2, 5, 10 years
measure: CTC-Incontinence
timeFrame: 2, 5, 10 years
measure: Progression-free survival "PFS"
timeFrame: 2, 5, 10 years
measure: Overall survival "OS"
timeFrame: 2, 5, 10 years
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Müller Arndt-Christian
Study officials:
References: