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Comparative Study of Radiotherapy Treatments to Treat High Risk Prostate Cancer Patients

NCT02303327 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 307

Last updated 2024-12-09

No results posted yet for this study

Summary

In North America, the number of new cases of prostate cancer increases every year. Many efforts have been made to develop more efficient and safer curative treatments for high risk prostate cancer patients.

This phase III clinical trial is designed to compare the safety of a standard pelvic external beam radiation therapy (EBRT) combined with a high dose rate brachytherapy (HDRB) boost (direct insertion of radiation source over a period of minutes via flexible needles temporarily inserted in the prostate) to a shorter course of hypofractionated dose escalation radiotherapy (larger radiation dose per daily treatment) in patients with high risk prostate cancer.

The investigators plan to recruit 296 patients across Quebec who will be randomized in either treatment plan.

Conditions

Interventions

RADIATION

EBRT + HDR brachytherapy boost

Standard radiotherapy (EBRT, 23 fractions) with the addition of High Dose-Rate (HDR) brachytherapy boost within 3 weeks of beginning or finishing the EBRT.

RADIATION

Hypofractionated Dose Escalation Radiotherapy

Radiation therapy (higher radiation dose per treatment) will be given once a day, five days a week, over approximately 5 weeks.

DRUG

Androgen deprivation therapy

28 months of androgen deprivation therapy (injections every 4 months for a total of 28 months)

Sponsors & Collaborators

  • Sir Mortimer B. Davis - Jewish General Hospital

    lead OTHER

Principal Investigators

  • Tamim Niazi, MD · Jewish General Hospital, McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2026-12-31
Completion
2029-01-31

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 NCT02303327 on ClinicalTrials.gov