Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

Rigshospitalet

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Urological Manifestations; Prostatic Neoplasm; Prostatic Diseases

Treatments: Procedure: Prostatic Artery Embolization

Study type: Interventional

Funder types: Other

Identifiers

NCT03104907

H-17000714-2

Details and patient eligibility

About

The aim of this study is to investigate the safety and efficacy of prostatic artery embolization of patients with recurrent symptoms secondary to locally advanced prostatic cancer including pelvic pain, bleeding or need for permanent urinary catheter who are unfit for or refuse surgical treatment.

Full description

This is a prospective study investigating the safety and efficacy of PAE for patients with prostate cancer who suffers from acute urinary retention, severe LUTS and/or recurrent complications such as haematuria.

Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS and QoL 12 months post-procedure.

1, and 6 months follow-up.

Main outcome Ability to void after removal of indwelling catheter

Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)

Enrollment: 15 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indwelling catheter secondary to locally advanced prostate cancer (PCa) or
• Moderate-severe Obstructive LUTS secondary to PCa
• Unsuitable for or refuse surgery

Exclusion criteria

• Bladder dysfunction(and known neurological conditions affecting bladder function)
• Urethral strictures
• Bladder neck contracture
• Known sphincter anomalies
• Big bladder diverticulum or stones
• Kidney insufficiency (eGFR < 45)
• Coagulation disturbances
• Severe atheromatous or tortuosity of arteries
• Allergy to contrast medium
• Unable to undergo MR imaging
• Bladder malignancy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Prostatic Artery Embolization

Experimental group

Description:

Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume.

Treatment:

Procedure: Prostatic Artery Embolization