Holmium laser treatment for prostate cancer patients with urinary symptoms
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
This study tests if using a special laser treatment for prostate issues can help men with prostate cancer who have bothersome urinary symptoms feel better before they start radiation therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT03802851 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of holmium laser enucleation of the prostate (HoLEP) on men suffering from bothersome lower urinary tract symptoms (LUTS) who are also diagnosed with prostate cancer and have chosen radiation therapy as their primary treatment. The study aims to determine whether performing HoLEP prior to radiation therapy can alleviate LUTS and potentially reduce the need for subsequent radiation treatments. By exploring the relationship between prostate cancer and LUTS, the trial seeks to inform future treatment protocols and improve patient care.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with bothersome LUTS and a confirmed diagnosis of prostate cancer who have opted for radiation therapy.
Not a fit: Patients with bladder cancer, prior prostate cancer treatments, or previous prostate surgeries will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life for patients by alleviating urinary symptoms and optimizing their cancer treatment.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Kansas
- University of Kansas Health System — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Bristol Whiles, MD — University of Kansas Medical Center
- Study coordinator: Jane Ledesma, BS
- Email: jledesma2@kumc.edu
- Phone: (913) 588-8721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.