HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer (HOLEP-RTPC)

University of Kansas

Status: Enrolling

Conditions: Lower Urinary Tract Symptoms; Prostate Cancer

Treatments: Procedure: Holmium Laser Enucleation of Prostate (HoLEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03802851

143226

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Holmium Laser Enucleation of Prostate (HoLEP)

Experimental group

Description:

Patients in this arm will undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms (LUTS). Patients will undergo HoLEP one time and will return for standard of care follow up.

Treatment:

Procedure: Holmium Laser Enucleation of Prostate (HoLEP)

Control Arm

No Intervention group

Description:

Patients in this arm will undergo no additional interventions and will not undergo holmium laser enucleation of the prostate (HoLEP) for the treatment of lower urinary tract symptoms and instead follow standard of care treatment and follow up.