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Search / Trial NCT03802851

HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Jan 10, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called holmium laser enucleation of the prostate (HoLEP) to see if it can help patients who have bothersome urinary symptoms and prostate cancer before they start radiation therapy. The goal is to find out if this treatment can improve their symptoms and potentially change the way their prostate cancer is treated.

To be eligible for this trial, participants must be at least 18 years old and have significant urinary issues, like a high symptom score or difficulty emptying their bladder. They also need to have a confirmed diagnosis of prostate cancer and have chosen radiation therapy along with hormone therapy as their main treatment. As part of the study, participants will undergo the HoLEP procedure, and their progress will be monitored to see how it affects their overall treatment. It's important to note that individuals with certain conditions, like bladder cancer or those who have had previous prostate surgery, cannot participate in this trial.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients must be 18 years of age or older
  • Patients must have bothersome lower urinary tract symptoms (LUTS), defined by American Urological Association Symptom Score (AUA SS) of greater than or equal to 15 and/or as defined by a post-void residual of greater than or equal to 350mL and/or as defined by catheter dependence
  • Patients must be diagnosed with prostate cancer by pathological tissue analysis
  • Patients must have elected for radiation with androgen deprivation therapy as the primary treatment modality for their prostate cancer
  • Exclusion Criteria:
  • Patients who are under 18 years of age are not eligible
  • Patients who have a diagnosis of bladder cancer are not eligible.
  • Patients with prior treatment for prostate cancer are not eligible.
  • Patients with any type of prior prostate surgery (minimally invasive, endoscopic, or otherwise) including prior transurethral resection of the prostate (but excluding prior prostate biopsy) are ineligible.
  • Patients with known metastatic prostate cancer are ineligible
  • Patients who are enrolled in other surgical or international trials at the time of this study are not eligible

About University Of Kansas Medical Center

The University of Kansas Medical Center (KUMC) is a leading academic medical institution dedicated to advancing healthcare through innovative research, education, and clinical practice. As a prominent clinical trial sponsor, KUMC leverages its extensive expertise in diverse medical fields to conduct rigorous clinical research aimed at improving patient outcomes and developing new treatment modalities. With a commitment to ethical standards and patient safety, KUMC collaborates with multidisciplinary teams to facilitate groundbreaking studies that address significant health challenges, ultimately contributing to the advancement of medical knowledge and the enhancement of community health.

Locations

Kansas City, Kansas, United States

Patients applied

0 patients applied

Trial Officials

Bristol Whiles, MD

Principal Investigator

University of Kansas Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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