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

Last updated: October 10, 2024
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Interstitial Cystitis

Prostate Cancer

Treatment

Holmium Laser Enucleation of Prostate (HoLEP)

Clinical Study ID

NCT03802851
143226
  • Ages > 18
  • All Genders

Study Summary

To determine if holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS) and/or urinary retention alters the treatment course for patients concurrently diagnosed with prostate cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be 18 years of age or older

  • Patients must have bothersome lower urinary tract symptoms (LUTS), defined byAmerican 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 350mLand/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 theprimary treatment modality for their prostate cancer

Exclusion

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, orotherwise) including prior transurethral resection of the prostate (but excludingprior 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 ofthis study are not eligible

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Holmium Laser Enucleation of Prostate (HoLEP)
Phase:
Study Start date:
September 19, 2019
Estimated Completion Date:
January 31, 2035

Study Description

The investigators propose a prospective trial to investigate pre-radiation holmium laser enucleation (HoLEP) in men with bothersome lower urinary tract symptoms (LUTS) and prostate cancer who have elected for radiation therapy as the primary treatment modality for their prostate cancer. The investigators hypothesize that pre-radiation HoLEP may decrease their overall LUTS and may decrease their need for subsequent radiation therapy. The goal with this study is to better understand the overlap between prostate cancer and LUTS, as well as determine if primary surgical treatment for the LUTS with HoLEP can also serve as a possible treatment modality for concurrent prostate cancer. This information may provide further information to inform future standard of care practices for patients with prostate cancer.

Connect with a study center

  • University of Kansas Health System

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

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