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NCT Number: NCT06817668

Evaluating Tolerability of ePUHRT With Brachytherapy Boost

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).

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

Location status: Recruiting

Location contact

Kathy Lauer

CONTACT

[email protected]

317-962-3172

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Radiation

ePURT 5Gy x 5 fractions delivered on noncontiguous weekdays with single HDR boost of 15Gy.

Primary outcomes

  1. Percentage of participants with acute grade ≥ 2 GU toxicity

    Time frame: 3 months

    Physician-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by CTCAE version 5.

Secondary outcomes

  1. Percentage of participants with acute grade ≥ 2 GI toxicity

    Time frame: 3 months

    Acute grade ≥ 2 GI toxicity at 3 months post ePUHRT with HDR boost by CTCAE version 5

  2. Percentage of participants with acute grade ≥ 2 GU toxicity

    Time frame: 3 months

    Self-reported acute grade ≥ 2 GU toxicity at 3 months post ePUHRT with HDR boost measured by PRO-CTCAE

Study contacts

Contact information is provided by the study sponsor or research team.

Kathy Lauer, BA

CONTACT

[email protected]

317-962-3172

Omar Ishaq, MD

CONTACT

[email protected]

317-944-2524

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Evaluating Tolerability of Elective Pelvic Ultra Hypofractionated Irradiation Treatment (ePUHRT) With High Dose Rate Brachytherapy Boost for Unfavorable and Higher Risk Prostate Cancer

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 10, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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