Prostatic Neoplasm, Lower Urinary Tract Symptoms, Urological Manifestations, Prostatic Diseases
Conditions
Keywords
IPSS, Quality of Life, DAN-PSS, Complications, Prostate cancer
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)
Interventions
PROCEDUREProstatic Artery Embolization
The procedure is performed with the patient under local anaesthetic and if necessary sedation. We will be using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation will be done using microspherical embolic material.
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to void spontaneously | 1 months | The ability to void after removal of the indwelling catheter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QoL | 1, 6 months | Quality of Life (scale) |
| IIEF | 1, 6 months | International Index of Erectile Function |
| PV | 1, 6 months | Prostate Volume |
| IPSS | 1, 6 months | International Prostate Symptom Score |
| Qmax | 1, 6 months | Peak void flow |
| PSA | 1, 24-hours, 6 months | Prostate-specific antigen |
| PVR | 1, 6 months | Post-void residual |
Countries
Denmark
Outcome results
None listed