Clinical trial NCT03802851: HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
Official title: HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lower Urinary Tract Symptoms
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Improvement in Quality of Life - One Year Post Operatively
timeFrame: Quality of life will be assessed one year post-operatively
measure: Improvement in Quality of Life - Five Years Post Operatively
timeFrame: Quality of life will be assessed five years post-operatively
Secondary outcomes:
measure: Prostate Cancer Treatment Course - One Year Post Operatively
timeFrame: Prostate Cancer Treatment Course will assessed one year post-operatively
measure: Prostate Cancer Treatment Course - Five Years Post Operatively
timeFrame: Prostate Cancer Treatment Course will assessed five years post-operatively
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Health System
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Bristol Whiles, MD
role: PRINCIPAL_INVESTIGATOR
References: