HoLEP Prior to Radiation Therapy for Patients With LUTS/Retention and Concurrent Prostate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Holmium Laser Enucleation of Prostate (HoLEP)
Procedure/SurgeryHolmium 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Holmium Laser Enucleation of Prostate (HoLEP)Experimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Quality of life will be assessed one year post-operatively2
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.
Time frame
Quality of life will be assessed five years post-operativelySecondary outcomes
1
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.
Time frame
Prostate Cancer Treatment Course will assessed one year post-operatively2
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.
Time frame
Prostate Cancer Treatment Course will assessed five years post-operativelySponsors and contacts
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Source ClinicalTrials.gov