Evaluating Tolerability of ePUHRT With Brachytherapy Boost
Recruiting · NCT06817668 · Interventional (participants receive a specific treatment) · Lead sponsor: Indiana University
View the official record on ClinicalTrials.gov →Interventions studied
ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- ≥ 18 years old at the time of informed consent
- Capable of providing informed consent and HIPAA authorization
- Karnofsky performance score ≥ 70
- Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
- Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
Exclusion criteria
- Prior pelvic irradiation treatment
- Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
- Evidence of nodal or distant disease on screening diagnostic work up.
- Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
- International Prostate Symptom Score (IPSS) score \> 16 despite medical therapy
Where it is running
1 location listed across 1 US state.
- Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis, Indiana, United States