Clinical trial · Interventional
MRI-Guided Radiation Therapy in Treating Patients Who Have Undergone Surgery to Remove the Prostate
A Prospective Study Implementing MRI Based Treatment Planning for Clinical Target Volume Definition and Immobilization in Post-Prostatectomy Radiation Treatment
- 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)
This is a prospective clinical trial examining the use of MRI to measure internal organ motion and any resulting changes in the target volume (shape and location) during a course of post-operative radiation therapy for prostate cancer. The goal is to better understand and characterize these physiologic variations so that they can be accounted for during the treatment planning process. The ultimate longer-term clinical goal here is to provide a form of adaptive radiation therapy in the future, such that if major changes are seen over an 8-week course of radiation therapy in our study. This may argue for hypofractionating those patients who are most likely to have major shifts over time.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| computed tomography | Procedure | — | UNRESOLVED |
| image-guided radiation therapy | Procedure | — | UNRESOLVED |
| intensity-modulated radiation therapy | Procedure | — | UNRESOLVED |
| magnetic resonance imaging | Procedure | — | UNRESOLVED |
| radiation therapy treatment planning/simulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo MRI and CT scan-based simulation for treatment planning with endorectal balloon target immobilization. The treatment target volumes and surrounding organs at risk are contoured, treatment plan developed and approved. Patients then undergo 39 fractions of image-guided intensity-modulated radiotherapy over 8 weeks. Patients also undergo weekly MRI scans of the pelvis (in the planned treatment position) during radiotherapy.
- interventionNames
- Procedure: radiation therapy treatment planning/simulation
- Procedure: intensity-modulated radiation therapy
- Procedure: image-guided radiation therapy
- Procedure: magnetic resonance imaging
- Procedure: computed tomography
Primary outcomes (2)
- measure
- Clinical treatment target motion and deformation as quantified by co-registration of weekly MRI scans with original treatment planning MRI scans
- measure
- Avoidance of any unexpected grade 3 or 4 toxicities
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Completion of a radical prostatectomy for adenocarcinoma of the prostate * Scheduled post-operative radiation therapy as part of the patient's treatment for prostate cancer * Subjects are capable of giving informed consent Exclusion * The presence of grossly visualized or palpable disease recurrence * Patients who are unable to undergo an MRI scan such as those with an implanted permanent pacemaker or ICD * Patients with metastatic disease or an increasing PSA
References
Publications (0)
Data not yet available