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
Recruiting
N/A
| Name | Type | Description | Interventions |
|---|---|---|---|
| MR-guided SBRT With SIB to the DILs to Prostate Cancer | Experimental | Dose escalation to the DIL(s) will be performed in the traditional Phase I 3+3 design. Patients will be treated in four cohorts (three patients per dose level) starting with a dose of 9 Gy to the DIL(s). If no dose limiting toxicity (DLT), defined below, is observed after 90 days, then an additional three patients will be entered at the next dose level. Dose to the DIL(s) will be escalated at 1 Gy increments until DLT is observed or if maximum dose level (60 Gy in 5 fractions of 12 Gy) is reached with no observed DLT. If one of the three patients experience a DLT at a particular dose level an additional three patients will be enrolled at that level. If two or more patients experience a DLT a lower dose level will be explored to define the maximum tolerated dose (MTD). The three patients within any cohort can be enrolled simultaneously or sequentially without any waiting period among them. |
Inclusion Criteria:
- Histologically confirmed prostate adenocarcinoma.
- Patients with low or favorable intermediate risk prostate cancer and patients with
unfavorable intermediate risk prostate cancer who decline androgen deprivation therapy
- Pretreatment evaluations must be completed as specified in Section 4.0
- Patients must sign a study-specific informed consent form prior to study
participation.
- No contraindication to MRI. For example, patients with metal fragments or implanted
devices such as pacemakers and aneurysm clips may not be eligible for the study
- At least one intraprostatic lesion can be identified on the mpMR images.
- Patients agree to have hydrogel placed.
Exclusion Criteria:
- Patients who have a contraindication to contrast-enhanced MRI are not eligible.
Patients with an implanted device such as a pacemaker or metal fragments are not
eligible.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
| Measure: | Determine the maximum tolerated dose to DILs until dose limiting toxicity (>=3 grade 3 GI/GU toxicity) is observed or if maximum dose level is reached |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT |
| Measure: | Quality of Life measures using the Epic questionnaire |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Henry Ford Health System |
May 2, 2019
