Recruiting

ePUHRT with Brachytherapy

Sponsor:

Indiana University

Code:

NCT06817668

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06817668

Start date

Mar 5, 2025

Status verified date

Sep, 2025

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

31 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Percentage of participants with acute grade ≥ 2 GU toxicity [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Omar Ishaq, MD

317-944-2524oishaq@iuhealth.org

Kathy Lauer, BA

317-962-3172KLauer@iuhealth.org

Locations

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Kathy Lauer

317-962-3172klauer@iuhealth.org

More Information

Sponsor

Indiana University

Last update posted

Sep 26, 2025

Last verified

Sep, 2025

Keywords

  • Brachytherapy boost

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-09-26.