Evaluating Tolerability of ePUHRT With Brachytherapy Boost

NCT06817668 | Recruiting DMC FDA Device

• 1 other identifier: CTO-IUSCCC-0832
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Prostate Cancer

Keywords

Brachytherapy boost

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Secondary Outcomes (2)

• Percentage of participants with acute grade ≥ 2 GI toxicity

  3 months

• Percentage of participants with acute grade ≥ 2 GU toxicity

  3 months

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Omar Ishaq, MD

  Indiana University Simon Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar Ishaq, MD

CONTACT

317-944-2524; oishaq@iuhealth.org

Kathy Lauer, BA

CONTACT

317-962-3172; KLauer@iuhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Urology

Study Record Dates

• First Submitted: October 9, 2024
• First Posted: February 10, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 26, 2025

Record last verified: 2025-09

Locations

US (1)