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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostatic Artery Embolization | Experimental | Embolization of the prostatic arteries to induce necrosis and a reduction of the prostate volume. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prostatic Artery Embolization | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to void spontaneously | The ability to void after removal of the indwelling catheter | 1 months |
| Measure | Description | Time Frame |
|---|---|---|
| IPSS | International Prostate Symptom Score | 1, 6 months |
| QoL | Quality of Life (scale) | 1, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Lönn, Professor | Radiologisk Klinik, Rigshospitalet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31062066 | Derived | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D011469 | Prostatic Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| IIEF | International Index of Erectile Function | 1, 6 months |
| PV | Prostate Volume | 1, 6 months |
| PVR | Post-void residual | 1, 6 months |
| Qmax | Peak void flow | 1, 6 months |
| PSA | Prostate-specific antigen | 1, 24-hours, 6 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |