CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 16 enrolled
Drug / intervention
5 Gy x 5 fractions +4 moreradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03663218
NCT03663218N/AActive
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PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

Weill Medical College of Cornell University·interventional·Posted Sep 10, 2018·Updated Mar 18, 2026

In Brief

A clinical study evaluating 5 Gy x 5 fractions, 6 Gy x 5 fractions, and 3 other interventions for Prostate Cancer. Active but no longer recruiting, targeting 16 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
Collaborators--

Timeline

N/AActive
2019202020212022202320242025202620272028
First PostedSep 10, 2018
Enrollment StartOct 24, 2018
Primary CompletionDec 31, 2023
Study CompletionDec 31, 2027
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 7.8 years ago

Interventions

5 Gy x 5 fractionsradiation

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 fractionsradiation

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 fractionsradiation

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)radiation

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)radiation

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.