Trials / Withdrawn
WithdrawnNCT03935308
Phase I Study MR-guided SBRT to PCa
Phase I Study Of MR-guided Stereotactic Body Radiotherapy (SBRT) With Simultaneous Integrated Boost (SIB) To the Dominant Intraprostatic Lesion(s) (DILs) in Men With Localized Prostate Cancer
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Henry Ford Health System · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
1\) investigate the feasibility, tolerance, and safety of dose escalation via MR-guided stereotactic body radiation therapy and simultaneous integrated boost to the dominant intraprostatic lesions (DILs), 2) to assess the feasibility of DIL visualization based on multi-parametric MRI (mpMRI), and 3) to characterize longitudinal changes in imaging characteristics and identify urinary biomarkers for treatment response prediction
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | MR guided Linear Accelerator | The aim is to perform treatment planning to compute the highest feasible simultaneous boosting dose to the intraprostatic lesion while respecting normal tissue dose constraints. Patients will be treated with MR-guided localization and adaptive planning techniques. |
Timeline
- Start date
- 2019-04-23
- Primary completion
- 2021-12-31
- Completion
- 2022-12-31
- First posted
- 2019-05-02
- Last updated
- 2022-02-25
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03935308. Inclusion in this directory is not an endorsement.