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Phase II High Dose Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer

NCT02960087 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2026-04-22

No results posted yet for this study

Summary

The purpose of this study is to evaluate the dose of High Dose Rate (HDR) brachytherapy chosen for this study as well as a commonly used alternate form of brachytherapy called low dose rate (or seed) brachytherapy. Investigators would like to understand how these treatments control the prostate cancer and look at their short and long term treatment related side effects.

The dose of radiation for HDR brachytherapy for this study has been changed since the study started. Other studies using the dose of radiation for HDR brachytherapy that was originally chosen for this study (Arm 2) found that this dose of radiation may be linked to a greater chance of the cancer coming back in the prostate. Therefore since March 2020, for new participants entering the study, a new HDR brachytherapy arm with a higher amount of radiation given over two doses will be tested in this study

Conditions

  • Prostate Carcinoma

Interventions

RADIATION

Low dose rate brachytherapy

I-125 to a total dose of 144 Gy

RADIATION

High dose rate brachytherapy

27 Gy in 2 fractions

Sponsors & Collaborators

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Gerard Morton · Sunnybrook Health Sciences, Toronto ON

  • Eric Vigneault · Hotel Dieu de Quebec, Montreal, QC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-06
Primary Completion
2029-04-30
Completion
2029-10-30

Countries

  • Canada

Study Locations

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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 NCT02960087 on ClinicalTrials.gov