Evaluating Tolerability of ePUHRT With Brachytherapy Boost

NCT ID: NCT06817668

Last Updated: 2025-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-05

Study Completion Date

2028-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Omar Ishaq

Assistant Professor of Clinical Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Ishaq, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Simon Comprehensive Cancer Center

Locations

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Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Omar Ishaq, MD

Role: CONTACT

317-944-2524

Kathy Lauer, BA

Role: CONTACT

317-962-3172

Facility Contacts

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Kathy Lauer

Role: primary

317-962-3172

Other Identifiers

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CTO-IUSCCC-0832

Identifier Type: -

Identifier Source: org_study_id

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