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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hypofractionated image-guided radiotherapy<br>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. | Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with gastrointestinal GI and genitourinary GU toxicity of >/= G2 | Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80% | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT | Feasibility and tolerability of completing at least 2 of 4 MRIs during treatment | 6 months | 
| Rate of participants achieving local control | In case of PSA progress: No evidence of local recurrence detected by MRI | 2, 5, 10 years | 
| Rate of participants achieving regional control | In case of PSA progress: No evidence of regional recurrence detected by MRI | 2, 5, 10 years | 
| Rate of participants achieving Distant-metastasis-free survival DMFS | No evidence of distant metastases diagnosed by cross-sectional imaging including bone scan, MRI, CT and PET | 2, 5, 10 years | 
| Number of Participants with biochemical no evidence of disease bNED | biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml | 2, 5, 10 years | 
| Time without secondary treatment TWIST | Time without secondary treatment calculated from start of IGRT | 2, 5, 10 years | 
| CTC-Proctitis | CTC 4.0 | 2, 5, 10 years | 
| CTC-Incontinence | CTC 4.0 | 2, 5, 10 years | 
| Progression-free survival PFS | progression-free survival is defined as any progression (biochemical or other recurrences) or death or initiation of secondary treatment, calculation from start of IGRT | 2, 5, 10 years | 
| Overall survival OS | Overall survival is calculated from start of IGRT | 2, 5, 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypofractionation, MR-based IGRT, Mbase HyPro