Prostate Cancer
Conditions
Keywords
hypofractionation, MR-based IGRT, Mbase HyPro
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
Interventions
RADIATIONPlan adaptation of Radiation Treatment in case of anatomical changes
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.
Sponsors
University Hospital Tuebingen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase II, Intervention: Plan adaption in case of significant changes of organ at risk or target volumes measured in weekly MRIs
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of participants achieving local control | 2, 5, 10 years | In case of PSA progress: No evidence of local recurrence detected by MRI |
| 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 |
| 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 |
| 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 |
| CTC-Proctitis | 2, 5, 10 years | CTC 4.0 |
| CTC-Incontinence | 2, 5, 10 years | CTC 4.0 |
| 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 |
| 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 |
Countries
Germany
Contacts
Primary ContactSilke Theden
Backup ContactArndt-Christian Müller
Outcome results
None listed