NCT03663218

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Male
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single-arm study including two parts. Part 1 will be a modified dose escalation and de-escalation study to determine maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) based on acute toxicity measures. Part 2 will be a cohort expansion study to further evaluate the safety and tolerability of the RP2D based on toxicities measured at 1 year. For Part 1, the primary endpoint is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative GU and/or GI grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days. For Part 2, the primary endpoint is to assess GU and/or GI grade 3 or higher toxicity based on CTCAE v5.0 at 1 year. The previously entered quality-of-life measure was removed to align the record with the primary and secondary endpoints as pre-specified in the IRB-approved protocol. Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-10-24
• Primary completion: 2023-12-31
• Completion: 2027-12-31
• First posted: 2018-09-10
• Last updated: 2026-03-18
• Results posted: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study