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RECRUITING
NCT00913939
NA

High-Dose-Rate Brachytherapy

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

Summary

This pilot study initiates a research program testing the early technical and clinical performance of a novel procedure for MRI-guided high-dose-rate (HDR) prostate brachytherapy. Testing will proceed in two cohorts of patients. In Arm 1, patients with locally recurrent prostate cancer after radiotherapy will receive tumor-targeted salvage HDR brachytherapy. Arm 1 of the study will be coordinated and closely integrated with a separate concurrent study of MRI-guided prostate biopsy, which will be performed prior to accrual to Arm 1 of this trial (UHN 05-0641-C). In arm 2, patients with locally advanced prostate cancer will receive a boost of prostate-targeted HDR brachytherapy during external beam radiotherapy. This technique will be prospectively evaluated in up to 100 patients. Preliminary data acquired in this pilot study will determine the technical limits of MRI guided HDR brachytherapy and will be critical for the judicious conduct of a subsequent phase II clinical trial. This proposal is innovative in two fundamental ways: MRI-guidance, and specific tumor targeting for HDR brachytherapy. Successful completion of this study will further individualize local therapy, not only for the benefit of the proportion of cancer patients for whom initial radiotherapeutic interventions have failed, but also provide valuable technical and clinical validation that these novel image-guided (IG) approaches are clinically feasible and could be applied more broadly in prostate cancer therapy.

Official title: MRI-Guided HDR Brachytherapy for Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2009-05

Completion Date

2025-05

Last Updated

2024-06-18

Healthy Volunteers

No

Interventions

PROCEDURE

MRI Guided Needles to deliver HDR Brachytherapy

Patients in this arm will receive two fractions (treatments) of brachytherapy over 14 days (+/- 7 days).

PROCEDURE

MRI Guided Needles to deliver HDR Brachytherapy

Patients in this arm will receive 2 fractions (treatments) of brachytherapy before the start of RT, and 4-5 weeks towards the end of EBRT.

Locations (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada