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Single Fraction HDR Brachytherapy Plus Hypofractionated EBRT for Low-risk Prostate Cancer: Phase II Trial

NCT02283346 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-11-05

No results posted yet for this study

Summary

The hypofractionated external radiation (EBRT) is a technique that radiation dose delivery using higher daily fractions than those used routinely. In this way can cause more damage tumor, especially in tissues that have a slower proliferation rate, as in the case of prostate cancer. Furthermore, achieves a reduction in total treatment time and probably a lesser chance of development of collateral in tissues of high multiplication rate as the lining of the rectum and bladder effects.

With brachytherapy boost for high dose rate is achieved by administering a more intense dose on the tumor and lower the sound around the region to be treated tissues, improving the therapeutic window.

Treatment with retracted and fully ambulatory time, has potential benefit as early patient return to usual activities and optimizing the flow of patients who require treatment with radiotherapy. This prospective study aims to assess the results and the toxicity profile of this treatment regimen retracted.

Conditions

  • Prostatic Neoplasms

Interventions

RADIATION

HDR brachytherapy + hypofractionated EBRT

Single Fraction High Dose Rate (HDR) Brachytherapy One fraction with 10-15 Gray (Gy) (depending on normal tissues constraints). \+ Hypofractionated External Beam Radiotherapy (EBRT) The treatment will be held with fractions 2.5 Gy per day, with a final dose between 25 and 50 Gy (depending on normal tissues constraints).

Sponsors & Collaborators

  • AC Camargo Cancer Center

    lead OTHER

Principal Investigators

  • Lucas G Sapienza, MD · AC Camargo Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • Brazil

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 NCT02283346 on ClinicalTrials.gov