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Recruiting NCT06817668

Evaluating Tolerability of ePUHRT With Brachytherapy Boost

Trial Parameters

Condition Prostate Cancer
Sponsor Indiana University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 31
Sex MALE
Min Age 18 Years
Max Age N/A
Start Date 2025-03-05
Completion 2028-10
Interventions
ePURT 5Gy x 5 fractions with single HDR boost of 15Gy

Brief Summary

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).

Eligibility Criteria

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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