Prostate CancerHOLEP-RTPCNCT03802851
HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
A study testing Holmium Laser Enucleation of Prostate (HoLEP) in people with Prostate Cancer and Lower Urinary Tract Symptoms, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Lower Urinary Tract Symptoms
- What is being tested?
- Holmium Laser Enucleation of Prostate (HoLEP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2019to Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Health System
Kansas City, Kansas, 66160
About this study
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.
Read the 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.
- Conditions
- Prostate Cancer, Lower Urinary Tract Symptoms
- Being tested
- Holmium Laser Enucleation of Prostate (HoLEP)
- Medical subject headings
- Prostatic Neoplasms, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Laser Enucleation of Prostate (HoLEP)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Holmium Laser Enucleation of Prostate (HoLEP) | Experimental | 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. Receives: Procedure: Holmium Laser Enucleation of Prostate (HoLEP) |
| Control Arm | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Quality of Life - 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.
Measured: Quality of life will be assessed one year post-operatively
Improvement in Quality of Life - 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.
Measured: Quality of life will be assessed five years post-operatively
Secondary outcomes (2)
Prostate Cancer Treatment Course - 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.
Measured: Prostate Cancer Treatment Course will assessed one year post-operatively
Prostate Cancer Treatment Course - 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.
Measured: Prostate Cancer Treatment Course will assessed five years post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start19 Sep 2019
- Primary completionJan 2030 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bristol Whiles, MD, University of Kansas Medical Center
- Investigators
- Bristol Whiles, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03802851
- Sponsor's protocol ID
- 143226
- Acronym
- HOLEP-RTPC
- Status last verified
- Jul 2026
- First submitted
- 3 Jan 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT03802851
- Acronym / sponsor ID
- HOLEP-RTPC / 143226
- Conditions
- Prostate Cancer, Lower Urinary Tract Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Holmium Laser Enucleation of Prostate (HoLEP) | Experimental | Procedure: 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. |
| Control Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Holmium Laser Enucleation of Prostate (HoLEP) |
Primary outcome
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.
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.
2 secondary outcomes
Prostate Cancer Treatment Course - One Year Post Operatively
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bristol Whiles, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holmium Laser Enucleation of Prostate (HoLEP) in people with Prostate Cancer and Lower Urinary Tract Symptoms, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jane Ledesma, BS ((913) 588-8721, jledesma2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Quality of Life - One Year Post Operatively (time frame: Quality of life will be assessed one year post-operatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.