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Prostate CancerProstate healthMen's healthRadiationPhase 1, Phase 2

What this study is

The purpose of this research study is to learn more about the outcomes and early and late side effects of treating early stage prostate cancer with high dose rate brachytherapy.

What's being tested

  • HDR brachytherapy

    Intervention · RADIATION

    * Dose constraints for 21 Gy: * Bladder and rectum: V70 < 1 cc * Urethra: V115 < 1 cc * V135: 0% * Dose constraints for 23 Gy: * Bladder and rectum: V65 < 1 cc * Urethra: V105 < 1 cc * V125: 0% * Dose constraints for 25 Gy: * Prostate V100 >90% (>95% preferred) * Bladder and rectum: V70 < 1 cc, Dmax <115% * Urethra: V110 < 1 cc, Dmax <120%

Study details

Official title
A Phase I/II Dose-escalation Study Evaluating the Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy
Sponsor
Washington University School of Medicine
Conditions
Prostate Cancer · Prostate Neoplasm
Enrolling
36 people
Starts
2018-02-27
Est. completion
2030-02-28
Design
Open-label, non-randomized, sequential groups, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗