- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03802851
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer (HOLEP-RTPC)
November 15, 2022 updated by: University of Kansas Medical Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jane Ledesma, BS
- Phone Number: (913) 588-8721
- Email: jledesma2@kumc.edu
Study Locations
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- Recruiting
- University of Kansas Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Quality of Life - One Year Post Operatively
Time Frame: 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.
|
Quality of life will be assessed one year post-operatively
|
Improvement in Quality of Life - Five Years Post Operatively
Time Frame: 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.
|
Quality of life will be assessed five years post-operatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prostate Cancer Treatment Course - One Year Post Operatively
Time Frame: 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 will assessed one year post-operatively
|
Prostate Cancer Treatment Course - Five Years Post Operatively
Time Frame: 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.
|
Prostate Cancer Treatment Course will assessed five years post-operatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 19, 2019
Primary Completion (Anticipated)
January 1, 2030
Study Completion (Anticipated)
January 1, 2035
Study Registration Dates
First Submitted
January 3, 2019
First Submitted That Met QC Criteria
January 10, 2019
First Posted (Actual)
January 14, 2019
Study Record Updates
Last Update Posted (Actual)
November 16, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 143226
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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