RECRUITING

Evaluating Tolerability of ePUHRT With Brachytherapy Boost

Talk to us

Conditions

Prostate CancerBrachytherapy boost

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2025-04
Study Completion:2028-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06817668

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥ 18 years old at the time of informed consent
  2. 2. Capable of providing informed consent and HIPAA authorization
  3. 3. Karnofsky performance score ≥ 70
  4. 4. Pathologically confirmed unfavorable intermediate, high, and very high-risk prostate cancer per treating physician
  5. 5. Candidate plans to undergo the standard of care prostate high dose brachytherapy boost procedure
  6. 6. Up to date colon cancer screen per per American Cancer Society guidelines
  1. 1. Prior pelvic irradiation treatment
  2. 2. Prior rectal surgery which precludes instrumentation with rectal ultrasound probe.
  3. 3. Evidence of nodal or distant disease on screening diagnostic work up.
  4. 4. Prior prostatectomy, Holmium laser enucleation of the prostate or transurethral resection of the prostate procedure
  5. 5. International Prostate Symptom Score (IPSS) score \> 16 despite medical therapy

Contacts and Locations

Study Contact

Omar Ishaq, MD
CONTACT
317-944-2524
oishaq@iuhealth.org
Nikki Barrow, BA
CONTACT
317-944-0260
nrbarrow@iu.edu

Principal Investigator

Omar Ishaq, MD
PRINCIPAL_INVESTIGATOR
Indiana University Simon Comprehensive Cancer Center

Study Locations (Sites)

Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Omar Ishaq, MD, PRINCIPAL_INVESTIGATOR, Indiana University Simon Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2028-10

Study Record Updates

Study Start Date2025-04
Study Completion Date2028-10

Terms related to this study

Keywords Provided by Researchers

  • Brachytherapy boost

Additional Relevant MeSH Terms

  • Prostate Cancer