Clinical trial · Interventional
MRI Guided SBRT for Localized Prostate Cancer
Prospective Evaluation of Multi-Parametric MRI Guided Stereotactic Body Radiotherapy (SBRT) for Localized Prostate Cancer
- 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 study utilizes advanced imaging techniques (mpMRI prostate scan) to select and stratify patients for two different radiotherapy regimens based on the presence/absence of identifiable intraprostatic lesions. In patients without identifiable prostate cancer lesions, SBRT to the prostate in 5 sessions (fractions) will be administered. In patients with MRI-identified lesion(s), pelvic IMRT in 25 fractions will be administered followed by an SBRT prostate boost while simultaneously treating the prostate cancer lesion(s) to a higher dose in 3 fractions.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions | Radiation | — | UNRESOLVED |
| SBRT to whole prostate | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Negative mpMRI Prostate Scan
- description
- SBRT to the whole prostate
- interventionNames
- Radiation: SBRT to whole prostate
- type
- EXPERIMENTAL
- label
- Positive mpMRI Prostate Scan
- description
- IMRT to the prostate + seminal vesicles followed by SBRT boost to the whole prostate with SIB to MRI defined intraprostatic lesions
- interventionNames
- Radiation: IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions
Primary outcomes (1)
- measure
- Number of Participants With Late Radiation Induced Genitourinary and Gastrointestinal Toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven prostate adenocarcinoma within 1 year of randomization * NCCN Low to High Risk localized prostate cancer * Zubrod Performance Status 0-1 within 60 days prior to registration Exclusion Criteria: * Prior or concurrent invasive malignancy (except non-melanoma skin cancer) * Regional Lymph Node (N1) involvement * Distant Metastases (M1) involvement * History of prior pelvic irradiation (external beam radiotherapy or brachytherapy) * Prior chemotherapy * Severe, active co-morbidities (unstable angina and/or CHF; MI; COPD; liver disease; AIDS) * Acute bacterial or fungal infection requiring IV antibiotics * Inability to undergo MRI * Inability to receive fiducial markers
References
Publications (0)
Data not yet available