An interventional study of ePURT 5Gy x 5 fractions with single HDR boost of 15Gy in Prostate Cancer, sponsored by Indiana University. Recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
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).
Progression free survival from irradiation dose escalation has been demonstrated across multiple prospective randomized studies. Irradiation dose escalation delivered by dual therapy (consisting of external beam irradiation treatment with brachytherapy boost, a type of internal radiation) offers improved survival. Brachytherapy boost makes it possible to safely deliver higher irradiation dose to the prostate gland than can be achieved with dose escalation by standard fractionated external beam treatment.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 31 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm non-randomized non-inferiority study exploring tolerability of ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
Radiation: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.
Percentage of participants with acute grade ≥ 2 GU toxicity
Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5.
Time frame: 3 months
Percentage of participants with acute grade ≥ 2 GI toxicity
Acute grade ≥ 2 GI toxicity at 3 months post ePUHRT with HDR boost by CTCAE version 5
Time frame: 3 months
Percentage of participants with acute grade ≥ 2 GU toxicity
Self-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by PRO-CTCAE
Time frame: 3 months
Plan to share: Undecided
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Indiana University