NCT03323879

Combined LDR Boost and HDR Whole Gland

Dominant Intraprostatic Lesion Boost With Focused LDR Brachytherapy (BT) Integrated to Whole Prostate HDR BT: Safety and Feasibility Analysis

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a dose finding Phase I/II study of combined focused LDR brachytherapy boost with whole gland single fraction HDR for men with low and intermediate risk prostate cancer and Dominant Intraprostatic Lesion (DIL) visible on multi parametric MRI. Patients will receive 19 Gy HDR to the whole gland with concurrent LDR brachytherapy boost to the DIL, in a sequential dose escalation manner. Primary endpoints are early toxicity.

Detailed description

Eligible patients will have low and intermediate risk prostate cancer with a dominant intraprostatic lesion definable on multi parametric MRI (PIRADS 4 or 5). Patients will have MR planned LDR focal brachytherapy to the DIL using iodine-125, while at the same time have single 19 Gy delivered to the whole prostate using ultrasound directed high dose-rate brachytherapy (HDR). The LDR boost dose will start at 50 Gy, and increase DIL dose in sequential cohorts of patients up until a dose of 80 Gy. Up to 20 patients will be included. Primary endpoint is toxicity at 3 months.

Conditions

• Carcinoma Prostate

Interventions

Type	Name	Description
RADIATION	LDR/HDR	Focal LDR to dominant lesion with whole gland 19 Gy HDR

Timeline

• Start date: 2017-10-30
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2017-10-27
• Last updated: 2021-04-27

Locations

1 site across 1 country: Canada