Clinical trial NCT03104907: Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer
Official title: Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Lower Urinary Tract Symptoms
Urological Manifestations
Prostatic Diseases
Keywords: IPSS
Quality of Life
DAN-PSS
Complications
Prostate cancer
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 15
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Ability to void spontaneously
timeFrame: 1 months
Secondary outcomes:
measure: IPSS
timeFrame: 1, 6 months
measure: QoL
timeFrame: 1, 6 months
measure: IIEF
timeFrame: 1, 6 months
measure: PV
timeFrame: 1, 6 months
measure: PVR
timeFrame: 1, 6 months
measure: Qmax
timeFrame: 1, 6 months
measure: PSA
timeFrame: 1, 24-hours, 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Radiologisk Klinik, Rigshospitalet
name: Lars Lönn, Professor
role: STUDY_CHAIR
References:
citation: Malling B, Roder MA, Lindh M, Frevert S, Brasso K, Lonn L. Palliative Prostate Artery Embolization for Prostate Cancer: A Case Series. Cardiovasc Intervent Radiol. 2019 Oct;42(10):1405-1412. doi: 10.1007/s00270-019-02227-4. Epub 2019 May 6.