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

Clinicaltrials.gov ID: NCT03802851
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 30

Conditions

Prostate Cancer, Lower Urinary Tract Symptoms

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.

Detailed 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.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Central Contacts

Principal Investigator

  • Bristol Whiles, MD

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

Study Plan

Holmium Laser Enucleation of Prostate (HoLEP)

EXPERIMENTAL

Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.

  • PROCEDURE:

    Holmium Laser Enucleation of Prostate (HoLEP)

    Description:

    Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment use for men with bothersome lower urinary tract symptoms (LUTS) to improve their LUTS. During the procedure a thin telescope-like instrument is inserted into the urethra. The high-powered laser is then inserted through this instrument and used to carefully remove the excess prostate tissue that is causing obstruction of the urethra and contributing to the patient's lower urinary tract symptoms.

Control Arm

NO_INTERVENTION

Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.

    Outcome Measures

    Primary Outcome Measures

    Improvement in Quality of Life - One Year Post Operatively

    Time Frame: Quality of life will be assessed one year post-operatively

    Improvement in Quality of Life - Five Years Post Operatively

    Time Frame: Quality of life will be assessed five years post-operatively

    Secondary Outcome Measures

    Prostate Cancer Treatment Course - One Year Post Operatively

    Time Frame: Prostate Cancer Treatment Course will assessed one year post-operatively

    Prostate Cancer Treatment Course - Five Years Post Operatively

    Time Frame: Prostate Cancer Treatment Course will assessed five years post-operatively

    Timeline

    • Last Updated
      October 15, 2024
    • Start Date
      January 14, 2019
    • Today
      February 5, 2025
    • Completion Date ( Estimated )
      January 1, 2035

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