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Toxicity Comparison Between Hypofractionated Radiotherapy With HDR Brachytherapy Boost Versus Standard Treatment

NCT01851018 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-03-21

No results posted yet for this study

Summary

The purpose of this study is to compare toxicities between 2 external beam radiation fractionation schemes plus a brachytherapy boost for prostate cancer. Our current standard use a 2 Gy per fraction schedule which is compare to the experimental hypofractionated 3 Gy per day approach with neo adjuvant hormonal therapy. It will demonstrate the feasibility and safety of such a treatment regimen in prostate cancer. It may also set base for a larger randomized trial.

Conditions

Interventions

RADIATION

Hypofraction

Patient reported toxicities related to Hypofraction radiation treatment (3 Gy daily, 5 fractions per week) up to a total of 36 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant firmagon (240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL as a starting dose with a maintenance dose of 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL administered every 28 days).

RADIATION

Standard

Patient reported toxicities related to the Standard radiation treatment (2 Gy daily, 5 fractions per week) up to a total of 44 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant LHRH agonists

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    collaborator INDUSTRY

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Andre-Guy Martin, MD MSc · CHUQ L'Hotel Dieu de Quebec

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2024-06-30
Completion
2025-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT01851018 on ClinicalTrials.gov