RecruitingPhase 1Phase 2NCT03424850

Safety and Efficacy of 21 Gy, 23 Gy and 25 Gy for High Dose Rate (HDR) Prostate Brachytherapy

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

Enrollment

36 participants

Start Date

Feb 27, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing three different radiation doses for a high-dose-rate brachytherapy procedure (where a radiation source is placed temporarily inside the prostate) to find the safest and most effective single dose for men with early-stage prostate cancer. **You may be eligible if...** - You have been diagnosed with early-stage prostate cancer confirmed by biopsy or cell testing - Your cancer is classified as low-risk (small tumor, low Gleason score, and PSA under 10) or favorable intermediate-risk (slightly higher Gleason score but limited spread) - You may have received hormone therapy prior to this treatment **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or other organs - You have had prior radiation to the pelvic area - You have very large prostate gland size that would make the procedure technically difficult - You have serious urinary blockage problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONHDR brachytherapy

* 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%


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT03424850


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