High Dose Rate Prostate Brachytherapy: Dose Escalation to Dominant Intra-prostatic Nodule

NCT01605097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-07-21

Study results available
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Summary

This study will investigate the feasibility of using technology of ultrasound guided HDR brachytherapy to focally increase dose to regions within the prostate that are heavily infiltrated with cancer. Such regions, referred to as dominant intraprostatic lesions (DIL) can be visualized using diffusion contrast enhanced MRI employing an endo-rectal coil. The magnetic resonance (MR) images can be fused with the planning transrectal ultrasound (TRUS) prior to the brachytherapy procedure to design a dose distribution that will encompass the malignant volume with higher than the prescription dose. By its nature, brachytherapy has subvolumes that receive (for example)125% of the prescription dose or 150% of the prescription dose. With TRUS-guided and TRUS-planned HDR these areas can be manipulated to coincide with the DIL. The limit of dose escalation has been reached at whole prostate external beam doses of 81-86 Gy and still failure rates for intermediate and high risk disease are unacceptable. There is much interest in focal dose escalation and TRUS-guided HDR brachytherapy is perfectly suited to achieving this.

Conditions

Interventions

RADIATION

HDR interstitial brachytherapy

2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy

Sponsors & Collaborators

  • British Columbia Cancer Agency

    lead OTHER

Principal Investigators

  • Matthew Schmid, MSc · Medical Physicst

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-07-31
Completion
2018-07-31

Countries

  • Canada

Study Locations

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Entities

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 NCT01605097 on ClinicalTrials.gov