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Randomized MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy
Sponsor: University of Miami
Summary
The purpose of this research study is to learn about: 1) improving control of prostate cancer using an extra high dose radiation treatment to the MRI defined high risk tumor areas, in addition to the standard radiation treatment to the rest of the prostate; 2) preserving quality of life by reducing dose to the nearby organs at risk around the prostate; and 3) establishing the relationship of pre- and post-treatment MRI to MRI-directed biopsy results at 2-2.5 years after treatment.
Official title: A Phase II Randomized Trial of MRI-Guided Prostate Boosts Via Initial Lattice Stereotactic vs Daily Moderately Hypofractionated Radiotherapy - The Miami BLaStM Trial
Key Details
Gender
MALE
Age Range
35 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
164
Start Date
2015-02-05
Completion Date
2031-07-31
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
LEAD RT
The multiparametric-MRI (MP-MRI) defined Gross Tumor Volume (GTV) will receive 12-14 Gy on the first day of treatment and then the prostate plus proximal seminal vesicles (SV), the Clinical Target Volume (CTV)1, will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs may be treated to 56 Gy in 38 Fxs or full dose (CTV2), and the pelvic lymph nodes may be treated to 56 Gy in 38 Fxs (CTV3).
HEIGHT RT
The MRI defined GTV(s) will receive a higher dose per day than the CTV by dose painting. The GTV(s) will receive an absolute dose of 91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 98.5 Gy in 2.0 Gy fractions. The prostate plus proximal seminal vesicles (CTV1) will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs (CTV2) may be treated to 56 Gy in 38 Fxs or full dose, and the pelvic lymph nodes (CTV3) may be treated to 56 Gy in 38 Fxs.
Locations (1)
University of Miami
Miami, Florida, United States