Trials / Completed
CompletedNCT03104907
Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- Male
- Age
- —
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Prostatic 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. |
Timeline
- Start date
- 2017-03-22
- Primary completion
- 2018-11-27
- Completion
- 2018-11-27
- First posted
- 2017-04-07
- Last updated
- 2018-11-29
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03104907. Inclusion in this directory is not an endorsement.