Clinical trial · Interventional
MRI-guided Ultrahypofractionated SBRT Prostate Program
PROJECT#2: MRI-guided Local SBRT Prostate Program
NCT07132658CI-TRIAL-00093880not yet recruitingN/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)
The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.
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 |
|---|---|---|---|
| MR-Guided SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Initial Phase
- description
- Whole Gland 36.25Gy/5Rx
- interventionNames
- Radiation: MR-Guided SBRT
- type
- EXPERIMENTAL
- label
- Study Phase
- description
- Whole Gland 27Gy/2Rx
- interventionNames
- Radiation: MR-Guided SBRT
- type
- EXPERIMENTAL
- label
- Final Phase
- description
- Asymmetrical Whole Gland 27Gy/2Rx
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Optimal Inclusion Criteria * Patients with low to favorable intermediate-risk prostate cancer as per the NCCN stratification criteria . * No prior radiation therapy to the target areas * Expected patient survival \>5 years * Patient able to undergo a MRI exam Cautionary Inclusion Criteria * Suboptimal candidates for high-dose therapy such as elderly, frail patients or patients with large volume glands (i.e, \>60cm3) or extensive TURP in the prior 6-12 months should be considered cautionary indications. * Patients with higher risk but low volume disease not candidates for ENI may be treated on an individual basis Exclusion Criteria * Prior radiation therapy to the target areas * Expected patient survival below 5 years * Patient unable to undergo a MRI exam
References
Publications (0)
Data not yet available
No reference posted for this study.