RecruitingInterventional

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

NCT ID: NCT03802851Sponsor: University of Kansas Medical CenterLast updated: 2025-08-27

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.

Arms & interventions

ProcedureHolmium Laser Enucleation of Prostate (HoLEP)
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.

Outcome measures

Primary

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

Secondary

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

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

University of Kansas Health System

Kansas City, Kansas, 66160

Recruiting