ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001235392

Ethics application status

Approved

Date submitted

4/08/2017

Date registered

24/08/2017

Date last updated

24/08/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Prostate Artery Embolization for patients with lower urinary tract symptoms due to benign prostate hyperplasia

Scientific title

Efficacy of Prostate Artery Embolization for patients with lower urinary tract symptoms due to benign prostate hyperplasia

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

PRO-FLOW

Linked study record

Health condition

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

benign prostate hyperplasia

lower urinary tract symptoms

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Prostate Artery Embolization. This procedure is performed as a day case in Interventional Radiology under conscious sedation using fluoroscopy. A very small urinary catheter is placed into the bladder and filled with contrast medium. The prostate artery is accessed using the Seldinger technique into CFA. Guidewires and catheters are introduced through the sheath and Embozene microspheres are injected into the left and right side of the prostate artery. The procedure takes approximately one hour and is performed by a specialist Interventional Radiologist. The catheter is removed 4 hours post procedure and the patient is discharged home

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Surgery

Comparator / control treatment

TURP group. This is the gold standard treatment for benign prostatic hyperplasia. It involves pre admission checks, ECG and anaesthetic assessment, bloods for CBC, renal, LFT and group and hold. The patient has TURP under either general or spinal anaesthetic and the procedure can take 1 -3 hours. There is significant post operative discomfort. Usually the patient has a 3-4 day hospital stay with a large urinary catheter, bladder irrigations. Patients can be discharged without or with a catheter in situ if unsuccessful trial of void immediately post op

Control group

Active

Outcomes

Primary outcome [1]

Change in IPSS after 3 months

Timepoint [1]

3 months

Primary outcome [2]

Successful trial of voiding after removal catheter means being able to pass urine effectively and empty bladder completely. Good stream and the ability to start and stop flow

Timepoint [2]

6 weeks

Secondary outcome [1]

patient satisfaction evaluations as assessed by the IPSS

Timepoint [1]

6 weeks , 6, 12, 24 and 60 months

Eligibility

Key inclusion criteria

Willing, able and mentally competent to provide written consent
aged 40 years or older
lower urinary tract symptoms
IPSS > 8
QOL >3
Prostate gland >40g on transabdominal ultrasound
Vascular anatomy that in the opinion of the Interventional Radiologist is amenable to PAE as assessed on CTA
Adequate laboratory parameters: platelets >100 , INR <1.5, bilirubin <2, albumen >2.5, eGFR >60

Minimum age

40 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

Prior history of prostate surgery or TURP
prior radiation to the pelvis
prior embolization to the prosatate
acontractile detrusor
neurogenic lower urinary tract dysfunction
urethral stenosis
bladder stone with surgical indication
proven adenocarcinoma of the prostate
eGFR <50ml/min
complicated anatomical variant including prostate artery
ASA class 4-5
contrast allergy
significant psychiatric disorders

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

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

allocation not concealed

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

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

numbers of patients recruited are based on a power calculation. For the primary endpoint, changes in IPSS at 3 months will be compared using a one sided t-test with significance level 2.5%. A non-inferiority margin has been set aside at -3. The targeted standard deviation was estimated at 3.5. If there is truly no difference between the TURP and PAE in terms of the improvement in IPSS score, the 44 patients (22 in each arm) are required to be 80% sure that the lower limit of a one sided 97.5% confidence interval (or equivalency a 95% two-sided interval) will be above the non-inferiority limit of -3.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

30/08/2017

Actual

Date of last participant enrolment

Anticipated

1/08/2019

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Christchurch hospital

Address [1]

2 Riccarton Avenue
Christchurch 8011
New Zealand

Country [1]

New Zealand

Primary sponsor type

Hospital

Name

Christchurch hospital

Address

2 Riccarton Avenue
Christchurch 8011

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
Freyberg Building
20 Aitken Street
PO box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

01/06/2015

Approval date [1]

28/08/2015

Ethics approval number [1]

15/STH?119

Summary

Brief summary

The purpose of this trial is to evaluate the safety and effectiveness of percutaneous embolization of the prostate arteries as a minimally invasive image guided procedure for patients with lower urinary tract symptoms due to benign prostate hyperplasia with a prostate volume of more than 40g. Benign prostate hyperplasia is a significant health problem in New Zealand affecting over 50% of men older than 60 years. This leads to lower urinary symptoms (LUTS) eg weak urine stream, urgency and leaking and even acute urinary retention. Symptoms are initially treated with medication but many patient do need surgical intervention. Transurethral resection of the prostate (TURP) is the standard treatment for prostates smaller than 80g whereas larger prostates may require open surgical resection. Both operations are not without risk and many elderly patients are not good candidates for surgery. Percutaneous embolization of bilateral prostate arteries aims to mimic the effect of TURP or open resection of the prostate without exposing the patients to the risk of operation and anaesthesia. PAE decrease the blood supply to the prostate gland and causes the gland to shrink. This trial aims to assess the safety and efficacy of PAE and in the future offer patients another treatment option for BPH

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Martin Krauss

Address

Radiology Department
Christchurch hospital
2 Riccarton Avenue
Christchurch 8011

Country

New Zealand

Phone

+64 3 3641410

Fax

+64 3 3641893

martin.krauss@cdhb.health.nz

Contact person for public queries

Name

Martin Krauss

Address

Radiology Department
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011

Country

New Zealand

Phone

+64 3 3641410

Fax

+64 3 3641893

martin.krauss@cdhb.health.nz

Contact person for scientific queries

Name

Martin Krauss

Address

Radiology Department
Christchurch Hospital
2 Riccarton Avenue
Christchurch 8011

Country

New Zealand

Phone

+64 3 3641810

Fax

+64 3 3641893

mertin.krauss@cdhb.health.nz

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

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
Embase	Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.	2020	https://dx.doi.org/10.1002/14651858.CD012867.pub2
Embase	Minimally invasive treatments for lower urinary tract symptoms in men with benign prostatic hyperplasia: a network meta-analysis.	2021	https://dx.doi.org/10.1002/14651858.CD013656.pub2
Embase	Prostatic arterial embolization for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.	2022	https://dx.doi.org/10.1002/14651858.CD012867.pub3
Embase	Update on the management of benign prostatic hyperplasia and the role of minimally invasive procedures.	2023	https://dx.doi.org/10.1016/j.prnil.2023.01.002

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

Trial Review

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Documents added manually

Documents added automatically