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PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)
Sponsor: Weill Medical College of Cornell University
Summary
Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.
Key Details
Gender
MALE
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2018-10-24
Completion Date
2027-12-31
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
5 Gy x 5 fractions
In the arm "Part 1 - Arm 5 Gy x 5 fractions" the participants will receive a dose of 5 Gy for each RT fraction for a total of 5 fractions (total dose 25 Gy).
6 Gy x 5 fractions
In the arm "Part 1 - Arm 6 Gy x 5 fractions" the participants will receive a dose of 6 Gy for each RT fraction for a total of 5 fractions (total dose 30 Gy).
6.5 Gy x 5 fractions
In the arm "Part 1 - Arm 6.5 Gy x 5 fractions" the participants will receive a dose of 6.5 Gy for each RT fraction for a total of 5 fractions (total dose 32.5 Gy).
maximum tolerated dose (6.5 Gy x 5 fractions)
In the arm "Part 1 - MTD Expansion Cohort" participants will receive the dose established as the maximum tolerated dose (MTD) based on the previously tested dose levels.
recommended phase 2 dose (6.5 Gy x 5 fractions)
In the arm "Part 2 - Arm RP2D" participants will receive the dose established as the recommended phase 2 dose (RP2D) based on the previously tested dose levels.
Locations (1)
Weill Cornell Medicine
New York, New York, United States