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Prostate Boost Irradiation With Stereotactic Body RT (SBRT)

NCT03380806 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-04

No results posted yet for this study

Summary

A randomized controlled open-label trial in patients with high risk prostate cancer. Eligible and consenting patients will be randomly allocated to receive stereotactic body radiotherapy (SBRT) boost to prostate or conventional radiotherapy boost to prostate in 1:1 ratio. Prostate radiotherapy boost will be administered after standard pelvic radiotherapy. Subjects will be followed for 24 months post radiation treatment for Quality of Life assessment and toxicity.

Conditions

Interventions

DRUG

LHRH agonist

Standard LHRH agonist for 3 years

RADIATION

Pelvic Radiation

Pelvic Radiation

RADIATION

Stereotactic Body Radiotherapy (SBRT)

SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)

RADIATION

Conventional Radiotherapy (CRT) Prostate Boost

CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Juravinski Cancer Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-01-01
Completion
2022-01-01

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

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 NCT03380806 on ClinicalTrials.gov