Evaluating Tolerability of ePUHRT With Brachytherapy Boost

September 23, 2025 updated by: Omar Ishaq, Indiana University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Melvin and Bren Simon Comprehensive Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ePURT 5Gy x 5 fractions with single HDR boost of 15Gy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Omar Ishaq, MD, Indiana University Simon Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

February 5, 2025

First Posted (Actual)

February 10, 2025

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO-IUSCCC-0832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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