Evaluating Tolerability of ePUHRT With Brachytherapy Boost

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06817668
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Mar 5, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202
Kathy Lauer
[email protected]
317-962-3172

Find similar trials in Indianapolis, IN

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Indiana University Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, IN

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