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Evaluating Tolerability of ePUHRT With Brachytherapy Boost

RECRUITINGN/ASponsored by Indiana University
Actively Recruiting
PhaseN/A
SponsorIndiana University
Started2025-03-05
Est. completion2028-10
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

Locations1 site

Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
Kathy Lauer317-962-3172klauer@iuhealth.org

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