Lower Urinary Tract Symptoms, Prostate Cancer
Conditions
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.
Interventions
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.
Sponsors
University of Kansas Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life - One Year Post Operatively | Quality of life will be assessed 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. |
| Improvement in Quality of Life - Five Years Post Operatively | Quality of life will be assessed 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Treatment Course - One Year Post Operatively | Prostate Cancer Treatment Course will assessed one year post-operatively | The secondary objective is to determine if holmium laser enucleation of the prostate (HoLEP) alters the prostate cancer treatment course in patients. This will assessed by comparing the time from enrollment to the time of initiation of radiation therapy in patients in both arms. |
| Prostate Cancer Treatment Course - Five Years Post Operatively | Prostate Cancer Treatment Course will assessed five years post-operatively | The secondary objective is to determine if holmium laser enucleation of the prostate (HoLEP) alters the prostate cancer treatment course in patients. This will assessed by comparing the time from enrollment to the time of initiation of radiation therapy in patients in both arms. |
Countries
United States
Contacts
CONTACTJane Ledesma, BS
PRINCIPAL_INVESTIGATORBristol Whiles, MD
University of Kansas Medical Center
Outcome results
None listed