Benign Prostatic Hyperplasia Clinical Trial
— PROARTEOfficial title:
PROARTE -PROstate ARTery to Reduce the Symptoms of Benign Prostatic Hyperplasia
This is a trial to demonstrate the superiority of prostate artery embolization (PAE) over sham procedure in men with benign prostatic hyperplasia (BPH) induced lower urinary tract symptoms (LUTS). The trial will aim to enroll 108 patients at a 2:1 allocation over a 2 year period.
Status | Not yet recruiting |
Enrollment | 108 |
Est. completion date | August 1, 2026 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 45 Years to 90 Years |
Eligibility | Inclusion Criteria: - • Men =45 and =90 years presenting with benign prostatic hyperplasia with symptoms for at least 6 months that are refractory to medical management or in whom medications are contraindicated, not tolerated, or refused. - International Prostate Symptom Score (I-PSS) score 14 or greater. - Quality of Life (QoL) score = 3 - Peak urinary flow (Qmax) less than or equal to 12 mL/s with void volume >125mL. - Prostate volume greater than 30 cc as determined by ultrasound, MRI, or CT. - Personal risk <40% based on the University of Texas San Antonio prostate cancer risk calculator or having a negative prostate biopsy for cancer within the last 24 months. - Able to provide written consent. - Not participating in any other investigational drug or device studies. Exclusion Criteria: - • History of biopsy-proven prostate cancer - Renal insufficiency (glomerular filtration rates (GFR) less than 40mL/min/1.73 m2 who are not already on dialysis) - Prior prostate surgery or intervention, including trans-urethral resection of the prostate, balloon dilation, stent implantation, laser prostatectomy, radiation, UroLift®, or hyperthermia - Other bladder or urethral pathology requiring therapy, either in the past or currently, including neurogenic bladder, sphincteric abnormalities, bladder cancer, or other causes of bladder atonia. - Other causes of urinary obstruction, such as strictures of urethra or ureters, not related to BPH - Current decompensated congestive heart failure, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression. - Neurological disease, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, and previous spinal nerve surgery - Patients with platelet count <50,000/µL or International Normalized Ratio (INR) >1.8, unless corrected for the procedure - Active urinary tract infection. Patients must have a negative culture within 7 days of the procedure. - Allergy to iodinated contrast agents unless pre-treated by corticosteroids. - Acute urinary retention. - Post void residual (PVR) > 250 mL with urodynamic evidence of atonic bladder. Patients with a PVR >250 but urodynamic testing consistent with obstruction will be allowed. - Bladder stone within three months prior to the procedure. - Hematuria not evaluated by Urologist for causes other than BPH. - Previous rectal surgery (excluding hemorrhoidectomy) or history of rectal disease. - Prior pelvic irradiation or radical pelvic surgery. Imaging exclusion criteria: • Internal iliac artery occlusion as determined by either CT or MRI. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Society of Interventional Radiology Foundation |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International Prostate Symptom Score | A survey accessing patient symptomology from BPH induced LUTS | 6 months | |
Secondary | International Prostate Symptom Score | A survey accessing patient symptomology from BPH induced LUTS | 1, 3, 6, 9, 12, 24, 36 months | |
Secondary | Quality of Life | A survey accessing quality of life impact on patients from BPH induced LUTS. | 1, 3, 6, 9, 12, 24, 36 months | |
Secondary | Maximal urinary flow rate change from baseline | Maximal flow rate of urine stream | 6, 12, 24, and 36 months | |
Secondary | Post void residual change from baseline | Post void residual measures the volume of urine remaining in the bladder after complete emptying. | 6, 12, 24, and 36 months | |
Secondary | International Index of Erectile Function questionnaire (IIEF) | A questionnaire designed to asses erectile function | 1, 3, 6, 9, 12, 24, 36 months | |
Secondary | Freedom from secondary intervention to treat BPH | Recording of other surgical/procedural treatments with each procedure being recorded as an event. | 1, 3, 6, 9, 12, 24, 36 months | |
Secondary | Ejaculatory function | Ejaculatory function will be assessed utilizing a four item questionnaire. | 3, 6, 9, 12, 24, 36 months | |
Secondary | Urinary Continence | Urinary Continence will be assessed using a 2 item questionnaire | 1, 6, and 12 months | |
Secondary | Number of hospital days | Number of hospital days following the procedure will be recorded | 1 month | |
Secondary | Recover experience | Recover experience will be assessed using a quality of recovery visual analog scale | 1 month | |
Secondary | Adverse events | All procedure related adverse events will be recoreded | 7 days and 1, 3, 6, 9, 12, 24, 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04807296 -
Thulium Fiber Laser Enucleation of the Prostate (TFLEP) vs HoLEP With Moses Technology (m-HoLEP)
|
N/A | |
Recruiting |
NCT05574244 -
Comparison of Functional Outcomes of Ejaculation-preserving Partial Trans Urethral Resection of the Prostate With Complete Trans Urethral Resection of the Prostate for Benign Prostatic Obstruction
|
N/A | |
Recruiting |
NCT04288427 -
5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy
|
N/A | |
Not yet recruiting |
NCT04245566 -
Prostatic Artery Embolization vs. Pharmacotherapy for LUTS/BPH
|
Phase 3 | |
Completed |
NCT02509975 -
Safety and Efficacy of OCL 503 in Prostate Artery Embolization
|
N/A | |
Withdrawn |
NCT01967251 -
Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction
|
Phase 2 | |
Completed |
NCT03246880 -
Clinical Trial To Evaluate the Efficacy and Safety of CKD-397 in Benign Prostatic Hyperplasia Patients
|
Phase 3 | |
Completed |
NCT02283684 -
GreenLight Laser Photoselective Vaporization of the Prostate vs Bipolar Transurethral Vaporization of the Prostate; RCT
|
Phase 4 | |
Completed |
NCT02206243 -
Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia
|
||
Completed |
NCT01438775 -
Phase 3 Evaluation of Re-Injection of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
Phase 3 | |
Completed |
NCT01454349 -
Study of PRX302 for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia (BPH)
|
Phase 1/Phase 2 | |
Completed |
NCT01139762 -
A Study of Tadalafil Use With Finasteride in Men With Enlarged Prostates and Urinary Symptoms
|
Phase 3 | |
Completed |
NCT01152190 -
A Study in Benign Prostatic Hyperplasia
|
Phase 3 | |
Active, not recruiting |
NCT00400894 -
Annexin A3 (ANXA3) as Protein-Based Marker for Non-Invasive Molecular Diagnostics of Prostate Carcinoma
|
N/A | |
Unknown status |
NCT00381108 -
Study of the Effects of Pomegranate Tablets on Enlarged Prostates
|
Phase 1 | |
Completed |
NCT00224133 -
The Evaluation of the Safety of a New Drug for Benign Prostatic Hyperplasia Used for 9 Months
|
Phase 3 | |
Completed |
NCT00701779 -
Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
|
Phase 4 | |
Terminated |
NCT02962674 -
To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH.
|
N/A | |
Active, not recruiting |
NCT05415748 -
Deprescribing Tamsulosin in Older Men
|
Phase 4 | |
Recruiting |
NCT04853914 -
Evaluation of the Safety of the Treatment of Benign Prostatic Hyperplasia by High Intensity Focused Ultrasound.
|
N/A |