Clinical trial NCT05531240: Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE)
Official title: Transurethral Prostate Resection (TURP) vs. Prostate Artery Embolization (PAE): Open Multicentric Randomized Study for Evaluation of Outcomes, Complications, and Health Economics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transurethral Resection of Prostate Syndrome
Prostate Hyperplasia
Embolization, Therapeutic
Keywords: Prostate embolisation
PAE
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Centrallasarettet Västerås
name: Lasarettet i Enköping
name: Sormland County Council, Sweden
name: Helsingborgs Hospital
First posted: 2022-09-07
Enrollment: 104
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study focuses on the treatment of benign prostatic hyperplasia which causes lower urinary tract symptoms.

The purpose of the research project is to evaluate PAE in terms of both medical and health economic outcomes. To evaluate whether there are any differences in effect (IPSS), complications, costs and perceived quality of life compared with TUR-P.


Eligibility criteria: Inclusion Criteria:

* Benign prostatic hyperplasia where medical treatment has not helped or for other reasons has not been deemed applicable
* IPSS\>=8
* Prostate volume \[40-80\] ml measured via transrectal ultrasound
* Peak flow rate (Qmax) \<= 15 ml / s,
* Verified obstruction by urodynamic studies (cystometry)
* Surgery not contraindicated

Exclusion Criteria:

* Prostate cancer
* Severe atherosclerosis
* Kidney failure
* Urethral stricture
* Active cystitis or prostatitis
* Bladder stone.
* Neurogenic bladder disorder
* Contrast product allergy

Primary outcomes:
measure: Improvement of lower urinary tract symptoms
timeFrame: 24 months
measure: Health care costs
timeFrame: 24 months
Secondary outcomes:
measure: Adverse effects,
timeFrame: 24 months
measure: Quality of life (Short Form Health Survey [EQ-5D-5L ])
timeFrame: 24 months
measure: Erectile function
timeFrame: 24 months
measure: Prostate-Specific Antigen (PSA)
timeFrame: 24 months
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborgs Hospital
state: Region Skånes
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
state: Region Sörmland
city: Enköping
country: Sweden
facility: Lasarettet i Enköping
state: Region Uppsala
city: Västerås
country: Sweden
facility: Region Vastmanland Hospital
state: Västmanland
Study officials:
affiliation: CKF Västerås Uppsala university
name: Abbas Chabok
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.
citation: Hunter DJ, McKee M, Black NA, Sanderson CF. Health status and quality of life of British men with lower urinary tract symptoms: results from the SF-36. Urology. 1995 Jun;45(6):962-71. doi: 10.1016/s0090-4295(99)80116-2.
citation: Barry MJ, Fowler FJ Jr, O'Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT. The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992 Nov;148(5):1549-57; discussion 1564. doi: 10.1016/s0022-5347(17)36966-5.
citation: Young S, Golzarian J. Prostate embolization: patient selection, clinical management and results. CVIR Endovasc. 2019 Jan 18;2(1):7. doi: 10.1186/s42155-019-0049-1.
citation: Burnett AL, Wein AJ. Benign prostatic hyperplasia in primary care: what you need to know. J Urol. 2006 Mar;175(3 Pt 2):S19-24. doi: 10.1016/S0022-5347(05)00310-1.
citation: Pinheiro LC, Martins Pisco J. Treatment of benign prostatic hyperplasia. Tech Vasc Interv Radiol. 2012 Dec;15(4):256-60. doi: 10.1053/j.tvir.2012.09.004.
citation: Carnevale FC, Antunes AA, da Motta Leal Filho JM, de Oliveira Cerri LM, Baroni RH, Marcelino AS, Freire GC, Moreira AM, Srougi M, Cerri GG. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010 Apr;33(2):355-61. doi: 10.1007/s00270-009-9727-z. Epub 2009 Nov 12.
citation: McWilliams JP, Bilhim TA, Carnevale FC, Bhatia S, Isaacson AJ, Bagla S, Sapoval MR, Golzarian J, Salem R, McClure TD, Kava BR, Spies JB, Sabharwal T, McCafferty I, Tam AL. Society of Interventional Radiology Multisociety Consensus Position Statement on Prostatic Artery Embolization for Treatment of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: From the Society of Interventional Radiology, the Cardiovascular and Interventional Radiological Society of Europe, Societe Francaise de Radiologie, and the British Society of Interventional Radiology: Endorsed by the Asia Pacific Society of Cardiovascular and Interventional Radiology, Canadian Association for Interventional Radiology, Chinese College of Interventionalists, Interventional Radiology Society of Australasia, Japanese Society of Interventional Radiology, and Korean Society of Interventional Radiology. J Vasc Interv Radiol. 2019 May;30(5):627-637.e1. doi: 10.1016/j.jvir.2019.02.013. Epub 2019 Mar 27. No abstract available.
citation: Gao YA, Huang Y, Zhang R, Yang YD, Zhang Q, Hou M, Wang Y. Benign prostatic hyperplasia: prostatic arterial embolization versus transurethral resection of the prostate--a prospective, randomized, and controlled clinical trial. Radiology. 2014 Mar;270(3):920-8. doi: 10.1148/radiol.13122803. Epub 2013 Nov 13.
citation: Abt D, Hechelhammer L, Mullhaupt G, Markart S, Gusewell S, Kessler TM, Schmid HP, Engeler DS, Mordasini L. Comparison of prostatic artery embolisation (PAE) versus transurethral resection of the prostate (TURP) for benign prostatic hyperplasia: randomised, open label, non-inferiority trial. BMJ. 2018 Jun 19;361:k2338. doi: 10.1136/bmj.k2338.
citation: NICE Guidance - Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia: (c) NICE (2018) Prostate artery embolisation for lower urinary tract symptoms caused by benign prostatic hyperplasia. BJU Int. 2018 Jul;122(1):11-12. doi: 10.1111/bju.14404. No abstract available.