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

NCT03802851 | Recruiting

• 1 other identifier: 143226
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (2)

• Improvement in Quality of Life - One Year Post Operatively

  The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.

  Quality of life will be assessed one year post-operatively

• Improvement in Quality of Life - Five Years Post Operatively

  The primary object is to determine if holmium laser enucleation of the prostate (HoLEP) improves the quality of life in patients with concurrent prostate cancer who may undergo radiation therapy as well. Quality of life will be assessed using the Expanded Prostate Cancer Index Composite (EPIC) 26. This instrument evaluates patient function and bother after prostate cancer treatment using 26 items and scored on a 0-100 scale, with higher scores indicating a better health related quality of life.

  Quality of life will be assessed five years post-operatively

Secondary Outcomes (2)

• Prostate Cancer Treatment Course - One Year Post Operatively

  Prostate Cancer Treatment Course will assessed one year post-operatively

• Prostate Cancer Treatment Course - Five Years Post Operatively

  Prostate Cancer Treatment Course will assessed five years post-operatively

Study Arms (2)

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)

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.

Interventions

Holmium Laser Enucleation of Prostate (HoLEP) PROCEDURE

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.

Holmium Laser Enucleation of Prostate (HoLEP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol Whiles, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jane Ledesma, BS

CONTACT

(913) 588-8721; jledesma2@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a small scale study with initial enrollment of 20 patients in the treatment arm of the study and an additional 10 patients enrolled in the control arm of the study.

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 14, 2019
• Study Start: September 19, 2019
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2035
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

US (1)