ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001201369

Ethics application status

Approved

Date submitted

9/08/2017

Date registered

16/08/2017

Date last updated

16/06/2023

Date data sharing statement initially provided

27/03/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Prostate Artery Embolisation Assessment of Safety and Efficacy with preliminary and follow-up urodynamic studies (P-EASY PLUS)

Scientific title

Prostate Artery Embolisation Assessment of Safety and Efficacy with preliminary and follow-up urodynamic studies in men with symptomatic benign prostate hyperplasia (P-EASY PLUS)

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1200-4913

Trial acronym

U P-EASY PLUS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Benign prostate hyperplasia

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Surgery

Surgical techniques

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Prostate artery embolisation procedures are performed by interventional radiologists experienced in prostate artery embolisation. The procedure takes approximately 120 minutes. Procedures will be performed with a right femoral or left brachial artery approach, using 4- or 5- French sheaths. 5-Fr 125 cm Impulse (Merit Medical, Utah, USA) and 4-Fr 120 cm Cobra Glidecath (Terumo, New Jersey, USA) catheters are combined with 150 cm standard Glidewires (Terumo, New Jersey, USA) to access the internal iliac arteries. Microcatheters 2.0Fr Progreat (Terumo, New Jersey, USA) or 1.7Fr SL-10 (Stryker, Michigan, USA) are used to selectively catheterise the prostate arteries over microwires, either 0.016” Radifocus Guidewire GT (Terumo, New Jersey, USA) or 0.014” Synchro Standard (Stryker, Michigan, USA). Following selective catheterisation of the prostate arteries and positioning of the microcatheter tip within the distal prostate artery, an on-table Dyna CT scan using hand-injected 1-2 ml contrast (Ultravist 300, Bayer, Leverkusen, Germany) in a 3 ml Medallion syringe (Merit Medical, Utah, USA) is performed and reviewed in three planes to assess for non-prostatic enhancement. Once the operators are confident that no off-target enhancement is evident, a single unit syringe of 250 micron Embozene (Celenova Biosciences, Texas, USA) is prepared by diluting the Embozene particles with full contrast to 1/16 (6.25%) of the original concentration. Embolisation is then performed by slowly injecting the diluted particles until complete stasis of the prostate artery has been achieved.

Intervention code [1]

Treatment: Other

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Assessment of bladder function following a PAE as assessed by urodynamic studies. A urodynamic study (or bladder pressure study) is performed by a urologist using a computer which monitors the pressure in the bladder via a pressure transducer inserted in the rectum. There a two phases to the test; during the filling phase a sterile liquid is trickled into the bladder by a catheter; in the second phase, the liquid is voided by the patient. Throughout the process the pressure within the bladder is measured, in addition to sensation felt by the patient, flow rate of void and residual volume following void.

Timepoint [1]

12-months post procedure

Primary outcome [2]

Association between initial prostate volume (calculated based on average measurements by CT, MRI and ultrasound) and urodynamic outcomes (bladder pressure during filling and void, void flow rate and residual volume following void, as assessed by urodynamic studies) following a PAE

Timepoint [2]

12-months post-procedure

Primary outcome [3]

Change in severity of symptoms following a PAE as assessed by the international prostate symptom severity (IPSS) score

Timepoint [3]

3-months and 12-months post procedure

Secondary outcome [1]

Change in quality of life score following a PAE as assessed within the IPSS questionnaire

Timepoint [1]

3-months and 12-months post procedure

Secondary outcome [2]

Change in the need for medication use to treat lower urinary tract symptoms following a PAE, as assessed by a follow-up questionnaire designed specifically for this study

Timepoint [2]

3-months and 12-months post procedure

Eligibility

Key inclusion criteria

BPH with prostate volume > 40cc
Moderate-severe lower urinary tract symptoms (IPSS >8)
Peak urinary flow <12ml/sec
Obstructive urodynamics
Medically refractory lower urinary tract symptoms >6 months
Unsuitable for, or unwilling to undergo, surgical prostate resection, in consultation with a urological surgeon

Minimum age

50 Years

Maximum age

80 Years

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

Prostate malignancy
Neurogenic bladder
Renal failure eGFR <35ml/min
Severe contrast allergy
Severe peripheral vascular disease
Urethral or bladder pathology

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

14/03/2017

Date of last participant enrolment

Anticipated

1/01/2020

Actual

3/03/2021

Date of last data collection

Anticipated

25/11/2022

Actual

22/04/2022

Sample size

Target

120

Accrual to date

Final

105

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

The Wesley Hospital - Auchenflower

Recruitment hospital [2]

St Andrew's War Memorial Hospital - Brisbane

Recruitment postcode(s) [1]

4066 - Auchenflower

Recruitment postcode(s) [2]

4000 - Brisbane

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Wesley Medical Imaging

Address [1]

Wesley Medical Imaging
The Wesley Hospital
30 Chasely Street
Auchenflower, QLD, 4066

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Wesley Medical Imaging

Address

Wesley Medical Imaging
The Wesley Hospital
30 Chasely Street
Auchenflower, QLD, 4066

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UnitingCare Health Human Research Ethics Committee

Ethics committee address [1]

UnitingCare Health Human Research Ethics Committee
 The Wesley Hospital
 PO Box 499
 Auchenflower  Qld  4066

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

16/02/2017

Ethics approval number [1]

1520

Summary

Brief summary

Prostate artery embolisation (PAE) is an emerging, minimally invasive treatment for lower urinary tract symptoms caused by benign prostate enlargement. The first prospective trial of PAE in Australia was performed at The Wesley Hospital, and this project builds on those successful results. Whilst PAE was shown to be very effective at shrinking the prostate and relieving urinary tract symptoms during short-term follow-up, its impact on urodynamics, and the complex interplay between prostate obstruction and bladder function, is yet to be studied. 

This project aims to be the first study to comprehensively assess the impact of PAE on bladder function (urodynamics), as well as improvements in urinary symptoms and quality of life. The study will also compare the responses of patients with differing severity of prostate enlargement, and those with recurrent symptoms after a surgical resection. This information will be used to hopefully predict which patients are likely to best respond to a PAE, and can therefore be considered as an alternative to medical therapy or as an effective medium term precursor to more invasive surgical resection.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nicholas Brown

Address

Wesley Medical Imaging
30 Chasley St
Auchenflower
QLD 4065

Country

Australia

Phone

+61 7 33719588

Fax

research@i-med.com.au

Contact person for public queries

Name

Sepinoud Firouzmand

Address

Wesley Medical Imaging
30 Chasley St
Auchenflower
QLD 4065

Country

Australia

Phone

+61 7 33719588

Fax

research@i-med.com.au

Contact person for scientific queries

Name

Sepinoud Firouzmand

Address

Wesley Medical Imaging
30 Chasley St
Auchenflower
QLD 4065

Country

Australia

Phone

+61 7 33719588

Fax

research@i-med.com.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
12491	Ethical approval					373452-(Uploaded-28-01-2021-08-45-35)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Prostate artery Embolisation Assessment of Safety and feasibilitY (P-EASY): a potential alternative to long-term medical therapy for benign prostate hyperplasia	2018	https://doi.org/10.1111/bju.14504

N.B. These documents automatically identified may not have been verified by the study sponsor.

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