MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)
- Conditions
- Prostate Cancer
- Interventions
- Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes
- Registration Number
- NCT03880851
- Lead Sponsor
- University Hospital Tuebingen
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 78
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hypofractionated image-guided radiotherapy Plan adaptation of Radiation Treatment in case of anatomical changes 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.
- Primary Outcome Measures
Name Time Method Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2 2 years Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%
- Secondary Outcome Measures
Name Time Method Number of participants completing at least 2 of 4 MRI-examinations during course of IGRT 6 months Feasibility and tolerability of completing at least 2 of 4 MRIs during treatment
Rate of participants achieving local control 2, 5, 10 years In case of PSA progress: No evidence of local recurrence detected by MRI
Number of Participants with biochemical no evidence of disease "bNED" 2, 5, 10 years biochemical no evidence of disease according to Phoenix definition: nadir + 2ng/ml
Progression-free survival "PFS" 2, 5, 10 years progression-free survival is defined as any progression (biochemical or other recurrences) or death or initiation of secondary treatment, calculation from start of IGRT
Rate of participants achieving regional control 2, 5, 10 years In case of PSA progress: No evidence of regional recurrence detected by MRI
Rate of participants achieving Distant-metastasis-free survival "DMFS" 2, 5, 10 years No evidence of distant metastases diagnosed by cross-sectional imaging including bone scan, MRI, CT and PET
CTC-Proctitis 2, 5, 10 years CTC 4.0
Overall survival "OS" 2, 5, 10 years Overall survival is calculated from start of IGRT
Time without secondary treatment "TWIST" 2, 5, 10 years Time without secondary treatment calculated from start of IGRT
CTC-Incontinence 2, 5, 10 years CTC 4.0
Trial Locations
- Locations (1)
Müller Arndt-Christian
🇩🇪Tübingen, Germany