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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
United States
Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
Contact Information
Primary
Omar Ishaq, MD
oishaq@iuhealth.org
317-944-2524
Backup
Kathy Lauer, BA
KLauer@iuhealth.org
317-962-3172
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2028-10
Participants
Target number of participants: 31
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Indiana University

This content was sourced from clinicaltrials.gov