Dose Escalation to Dominant Intraprostatic Lesions (DIL) With MRI-TRUS Fusion High Dose Rate (HDR) Prostate Brachytherapy

NCT01909388 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-07-26

No results posted yet for this study

Summary

The Magnetic Resonance (MR) provides high resolution of soft tissue images allowing an appropriate assessment of the local extent of the disease. Recent studies have shown an increase in sensitivity and specificity for the detection of Dominant intraprostatic lesions when using multiparametric MRI as a diagnostic tool in the staging of the disease.

Among the various irradiation techniques currently available for prostate cancer, Brachytherapy is the superior in terms of dose conformation; this conformation allows greater dose escalation, adjusting the isodoses to the prostate with exquisite accuracy, keeping healthy adjacent organs, such as the urethra and rectum, in a tolerable dose range

Brachytherapy companies have recently developed software allowing for TRUS-MR image fusion.

The purpose of this study is to demonstrate the feasibility of the delivery of a higher than prescription dose to the dominant intra-prostatic nodule as defined on multiparametric MRI.

Dose to prostate, and adjacent structure will remain the same as the current treatment practice. Timing and the delivery of brachytherapy will not change from our current practice

Conditions

Interventions

RADIATION

MRI-TRUS fusion guided real time HDR

Sponsors & Collaborators

  • Hospital de Cruces

    collaborator OTHER
  • Alfonso Gomez-Iturriaga

    lead OTHER

Principal Investigators

  • Alfonso Gomez-Iturriaga, MD · Hospital de Cruces

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-05-31
Completion
2016-07-31

Countries

  • Spain

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 NCT01909388 on ClinicalTrials.gov