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Evaluating Tolerability of ePUHRT With Brachytherapy Boost

RecruitingNAAges 18 Years - anyMaleIndiana University
NCT06817668 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this study is to evaluate the tolerability and toxicity of combining two radiation therapy methods for prostate cancer: Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT), which is an external beam radiotherapy with High Dose Rate Brachytherapy Boost (form of internal radiation where a cancer doctor implants a small plastic tube or balloon (catheter) in the tumor).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Capable of providing informed consent and HIPAA authorization 3. Karnofsky performance score ≥ 70 4. Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician 5. Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure Exclusion Criteria: 1. Prior pelvic irradiation treatment 2. Prior rectal surgery which precludes instrumentation with rectal ultrasound probe. 3. Evidence of nodal or distant disease on screening diagnostic work up. 4. Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure 5. International Prostate Symptom Score (IPSS) score \> 16 despite medical therapy
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What it tests

  • ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
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Where

1 site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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