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

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03802851
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 183.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Lower Urinary Tract Symptoms	Procedure: Holmium Laser Enucleation of Prostate (HoLEP)	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
• Actual Study Start Date: Sep 19, 2019
• Anticipated Primary Completion Date: Jan 1, 2030
• Anticipated Study Completion Date: Jan 1, 2035

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Holmium Laser Enucleation of Prostate (HoLEP) 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.	Procedure: 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.
No Intervention: Control Arm 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Health System	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03802851
• Other Study ID Numbers: 143226
• First Posted: Jan 14, 2019
• Last Update Posted: Aug 3, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Prostatic Neoplasms; Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Aug 3, 2021