Actively Recruiting

Phase Not Applicable
Age: 18Years - 95Years
MALE
Healthy Volunteers
NCT05786742

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

Led by CHU de Quebec-Universite Laval · Updated on 2025-09-09

205

Participants Needed

1

Research Sites

1026 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \& 10 years.

CONDITIONS

Official Title

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

Who Can Participate

Age: 18Years - 95Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Biopsy proven Prostate adenocarcinoma
  • Clinical stage T1c or T2
  • Lymph node stage Nx or N0
  • Metastasis stage Mx or M0
  • PSA less than 20 ng/ml
  • Gleason Score 6 or 7
  • Ability to sign written consent
Not Eligible

You will not qualify if you...

  • Age less than 18 years
  • Clinical stage T3 or T4
  • Lymph node stage N1
  • Metastasis stage M1
  • PSA greater than 20 ng/ml
  • Gleason Score 8 to 10
  • IPSS Score greater than 20 despite alpha-blocking medication
  • Prior pelvic radiotherapy
  • History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
  • Past history of Inflammatory Bowel Disease
  • Presence of bilateral hip prosthesis

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

CHUdeQuebec

Québec, Canada, G1R 2J6

Actively Recruiting

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Research Team

A

Andre-Guy Martin

CONTACT

J

Josee Allard

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost. | DecenTrialz