Clinical trial · Interventional
MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)
Single-arm Phase (II) Study on MR-based Hypofractionated Adaptive Image-guided Radiation Therapy for Prostate Cancer
NCT03880851CI-TRIAL-00037701Mbase_HyProunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plan adaptation of Radiation Treatment in case of anatomical changes | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Hypofractionated image-guided radiotherapy
- 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.
- interventionNames
- Radiation: Plan adaptation of Radiation Treatment in case of anatomical changes
Primary outcomes (1)
- measure
- Number of participants with gastrointestinal "GI" and genitourinary "GU" toxicity of >/= G2
- timeFrame
- 2 years
- description
- Hypothesis: reduction of GI/GU-toxicity (CTC-criteria 4.0, RTOG) from 20% to 10% at 2 years, power 80%
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.