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HDR vs LDR Brachytherapy as Monotherapy in the Treatment of Localized Prostate Cancer.

NCT02258087 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2014-10-07

No results posted yet for this study

Summary

Investigators compare in a randomized clinical trial the results and side effects of high-dose- and low-dose-rate brachytherapy as monotherapy in the treatment of early, organ confined prostate cancer patients.

Conditions

  • Adenocarcinoma of Prostate

Interventions

RADIATION

LDR Brachytherapy

In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.

RADIATION

HDR Brachytherapy

In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.

Sponsors & Collaborators

  • National Institute of Oncology, Hungary

    lead OTHER

Principal Investigators

  • Peter Agoston, MD, PHD · NIO, Hungary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-09-30
Completion
2019-09-30

Countries

  • Hungary

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 NCT02258087 on ClinicalTrials.gov