Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT06052683

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

Led by CHU de Quebec-Universite Laval · Updated on 2026-02-17

208

Participants Needed

1

Research Sites

521 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma of the prostate diagnosed within the last 8 months, including patients on active surveillance with recent biopsy
  • Low-risk prostate cancer defined as clinical stage T1-T2a, Gleason score 6, and PSA 64 10 ng/mL
  • Favorable intermediate-risk cancer with one NCCN intermediate risk factor: clinical stage T2b, PSA > 10 but 64 20 ng/mL, or Gleason 7 (3+4)
  • Age 18 years or older
  • Eastern Cooperative Oncology Group performance status 0-1
  • Medically fit for LDR brachytherapy
  • Prostate volume 64 60 cc measured by TRUS, CT, or MRI within the last 6 months
  • International Prostate Symptom Score (IPSS) 64 20 (alpha blockers allowed)
  • No use of alpha reductase inhibitors within two weeks before randomization
  • No hormonal therapy
  • Willing and able to provide informed consent
  • Able and willing to complete EPIC-26, IPSS, and SHIM questionnaires
Not Eligible

You will not qualify if you...

  • Evidence of metastatic disease or nodal involvement
  • Clinical stage T2b or higher
  • Gleason score 4+3 or higher
  • History of other malignancies except treated non-melanoma skin cancer or other solid tumors with no disease for 64 3 years
  • Prior radical prostate surgery or Trans-Urethral Resection of the Prostate (TURP)
  • Prior pelvic radiotherapy or overlapping radiotherapy fields
  • Prior chemotherapy for prostate cancer or chemotherapy within the last 3 years
  • Prior cryosurgery of the prostate
  • History of bleeding disorders making procedures unsafe
  • Androgen deprivation therapy within 6 months before registration
  • Bilateral hip prostheses
  • Severe active comorbidities, lab abnormalities, psychiatric illnesses, infections, or conditions preventing participation (e.g., active inflammatory bowel disease or significant urinary symptoms)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre Intégré de Cancérologie, CHU de Québec-Université Laval

Québec, Quebec, Canada, G1J 1Z4

Actively Recruiting

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Research Team

I

Isabelle Thibault, MD, FRCPC

CONTACT

E

Eric Vigneault, MD, FRCPC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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