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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Holmium 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.

Первичные конечные точки

• Improvement in Quality of Life - One Year Post Operatively [Срок оценки: Quality of life will be assessed one year post-operatively]
• Improvement in Quality of Life - Five Years Post Operatively [Срок оценки: Quality of life will be assessed five years post-operatively]

Вторичные конечные точки (2)

• Prostate Cancer Treatment Course - One Year Post Operatively [Срок оценки: Prostate Cancer Treatment Course will assessed one year post-operatively]
• Prostate Cancer Treatment Course - Five Years Post Operatively [Срок оценки: Prostate Cancer Treatment Course will assessed five years post-operatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Kansas Health System — Kansas City

Идентификаторы

NCT: NCT03802851 · 143226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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