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ACTIVE NOT RECRUITING
NCT03663218
NA

PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

Sponsor: Weill Medical College of Cornell University

View on ClinicalTrials.gov

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

RADIATION

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).

RADIATION

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).

RADIATION

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).

RADIATION

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.

RADIATION

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