Prospective Controlled Randomized Study of PAE vs TURP for BPH Treatment.
NCT ID: NCT02566551
Last Updated: 2019-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-10-31
2019-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Prostate artery embolization
Prostatic artery embolization (PAE) To perform embolization, gelatin microspheres (300-500 microns) will be used in this arm
PAE
Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.
Gelatin microspheres
Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol
Transurethral resection of the prostate
Transurethral resection of the prostate (TURP) A bipolar electrosurgery generator will be used to perform TURP
TURP
Bipolar transurethral resection of the prostate
Bipolar electrosurgery generator
A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)
Interventions
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PAE
Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.
Gelatin microspheres
Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol
TURP
Bipolar transurethral resection of the prostate
Bipolar electrosurgery generator
A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
* Lower urinary tract symptoms (LUTS) secondary to BPH for at least 6 months prior to study AND/OR baseline IPSS Score \> 13 AND/OR acute urinary retention with impossibility to remove urinary catheter AND/OR BPH symptoms refractory to medical treatment or for whom medication is contraindicated, not tolerated or refused Prostate size of at least 50 grams measured by MRI
* Patient must meet ONE of the following criteria:
1. Baseline Prostate Specific Antigen (PSA) \<4 ng/mL (no prostate biopsy required)
2. Baseline PSA \>4 ng/mL and ≤10 ng/mL AND free PSA \> 15% of total PSA (no prostate biopsy required)
3. Baseline PSA \>4 ng/mL and ≤10 ng/mL AND free PSA \<15% of total PSA AND a negative prostate biopsy result (minimum 12 core biopsy)
4. Baseline PSA \>10 ng/mL AND a negative prostate biopsy (minimum 12 core biopsy)
Exclusion Criteria
* Patients with cystoscopy findings suspicious for bladder cancer must undergo biopsy and have a negative histopathology report to be enrolled in the study
* Biopsy proven prostate or bladder cancer
* The following patients must undergo prostate biopsy with a minimum of 12 cores and have a negative histopathology report to be enrolled in the study:
* Patients with digital rectal examination (DRE) findings suspicious for prostate cancer
* Patients with baseline PSA levels \> 10 ng/mL
* Patients with baseline PSA levels \>4 ng/mL and \< 10 ng/mL AND free PSA \< 15% of total PSA
* Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
* Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
* Allergy to iodinated contrast agents
* Hypersensitivity to gelatin products
* Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
* Known major iliac arterial occlusive disease or any known condition that catheterization of the prostatic arteries or is a contraindication to embolization, as vasospasm, anatomical variations that imply a risk of embolization, bleeding, prostatic arteries diameter inferior to microcatheter profile, pelvic inflammatory disease
* Contraindication to magnetic resonance imaging
* History of prostatitis in the last 5 years, not totally controlled with medical treatment
* History of pelvic irradiation or radical pelvic surgery
* Coagulation disturbances not normalized by medical treatment
40 Years
MALE
No
Sponsors
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Hospital Clínico Universitario Lozano Blesa
OTHER
Universidad de Zaragoza
OTHER
Group of Research in Minimally Invasive Techniques
OTHER
Responsible Party
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José A. Guirola, MD
MD
Principal Investigators
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Miguel A De Gregorio, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Zaragoza. Chairman of Radiology
Locations
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Hospital Universitario Lozano Blesa
Zaragoza, , Spain
Countries
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Other Identifiers
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GTM-02
Identifier Type: -
Identifier Source: org_study_id
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