NCT06052683

A Trial Evaluating Toxicity of SBRT and LDRB in Localized Prostate Cancer.

A Randomized Trial Evaluating Toxicity of Stereotactic Body Radiotherapy (SBRT) and Low-dose Rate Brachytherapy (LDRB) in Localized Prostate Cancer.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare SBRT (Stereotactic Body RadioTherapy) to LDRB (Low-Dose Rate Brachytherapy with Iodine-125 seed implant) in patients with low and favourable intermediate-risk prostate cancer. The two main questions it aims to answer are : 1. Does SBRT (Stereotactic Body RadioTherapy) for low and intermediate risk prostate cancer patients will result in less genito-urinary (GU) and gastro-intestinal (GI) toxicities than LDRB (Low-Dose Rate Brachytherapy)? 2. Does prostate cancer patients treated by SBRT have a better quality of life than patients treated by LDRB No randomized trial has yet compared LDRB to SBRT head to head.

Detailed description

Low-dose rate brachytherapy (LDRB) using Iodine-125 seed implant is known to be an effective definitive treatment for patients with low and favourable intermediate-risk prostate cancer. Mature data from Canadian institutions reported a biochemical progression-free survival as high as 90-95% at 5-10 years for patients with low and intermediate risk disease. Prostate Stereotactic Body Radiotherapy (SBRT) as a single modality is a promising alternative to LDRB in low and favourable intermediate-risk prostate cancer. Some studies have shown the feasibility and efficacy of SBRT with low to intermediate risk-prostate cancer with 5-7 years PSA-progression-free survival really high (89,8% to 97,1% at a median follow-up of 5-7 years) \[PSA: Prostate-Specific Antigen\]. No randomized trial has yet compared LDRB to SBRT head to head. Acute urinary toxicity is not trivial: a few studies have shown correlation between late urinary toxicity and the presence of acute urinary toxicity in patients treated with LDRB. Our research hypothesis is that SBRT for low and intermediate risk will result in fewer toxicities at the genito-urinary and the gastro-intestinal levels after 3 months of treatment.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
RADIATION	Low-Dose Rate Brachytherapy to the prostate using Iodine-125 seed implant	Low-dose rate brachytherapy with Iodine-125 to a total dose of 144 Gy
RADIATION	Stereotactic Body Radiation Therapy to the prostate	Prostate Stereotactic Body Radiation Therapy using 36.25 Gy in 5 fractions

Timeline

• Start date: 2019-09-30
• Primary completion: 2028-09-30
• Completion: 2029-09-30
• First posted: 2023-09-25
• Last updated: 2026-02-17

Locations

1 site across 1 country: Canada