Low or Intermediate Risk Prostate Cancer
Conditions
Keywords
prostate cancer, MRI, intraprostatic lesions
Brief 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
Interventions
RADIATIONMR 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.
Sponsors
American Cancer Society, Inc.
Henry Ford Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 years | The study aims to evaluate the safety and feasibility to employ a simultaneous integrated boost to MRI detected dominant intraprostatic lesion(s) during SBRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life measures using the Epic questionnaire | 2 years | Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data. |
Countries
United States
Outcome results
None listed