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

NCT06052683 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-02-17

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Isabelle Thibault, MD, FRCPC · CHU de Québec-Université Laval

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2028-09-30
Completion
2029-09-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06052683 on ClinicalTrials.gov