Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Urinary Bladder Neck Obstruction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urethral Obstruction

Urethral Diseases

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

PAE performed under local anesthesia using officially approved microspheres.

PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).

Prostatic Artery Embolization

Dominik Abt, MD

Gautier Müllhaupt, MD

This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.

PAE has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction.

Advanced (defined as locally advanced, metastatic or both in this study) PCA is frequently associated with both of these conditions. The currently most frequently performed palliative surgical treatment is TURP. Though performed endoscopically, TURP is associated with significant side effects in this setting. PAE has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to TURP.

In addition, there is growing evidence that patients with advanced PCA might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). However, recent methods of cytoreductive treatment of PCA hold the risk of being highly invasive and are associated with severe side effects. PAE might represent a minimally invasive alternative in this setting.

Therefore, efficacy and safety of PAE in patients with advanced prostate cancer is assessed in this pilot-study.

Prostatic Artery Embolization in Advanced Prostate Cancer

Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.

Decision will be made individually up on request and based on approval by our local ethics committee.

Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

Assessment of occurrence of hematuria according to CTCAE v.4.03 classification

Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))

Measurement of urinary stream (mL/s) by urinary flow rate measurement

Measurement of post void residual urine (mL) by transabdominal ultrasound

Assessment of number and type of reinterventions for prostate and bladder problems

Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE

Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate

Change of tumor volume calculated by magnetic resonance imaging

Change of prostate volume calculated by magnetic resonance imaging

Dominik Abt

Dr. med.

Symptoms and General Pathology

Behaviors and Mental Disorders

Lower Urinary Tract Symptoms

Urological Manifestations

Quality of Life

Anesthetics, Local

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

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.

Lars Lönn, Professor

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)

Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer

The ability to void after removal of the indwelling catheter

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prostatic Artery Embolization in Advanced Prostate Cancer	NCT03457805	Prostate Cancer Bladder Outlet ...	Prostatic Arter...	-	Cantonal Hospital of St. Gallen
Prostatic Artery Embolization for Obstructive Uropathy Due to Prostate Cancer	NCT03104907	Prostatic Neopl... Lower Urinary T... Urological Mani... Prostatic Disea...	Prostatic Arter...	-	Rigshospitalet, Denmark
Prostatic Artery Embolization in Advanced Prostate Cancer	NCT03457805	Prostate Cancer Bladder Outlet ...	Prostatic Arter...	-	Cantonal Hospital of St. Gallen

Spots Global Cancer Trial Database for prostatic artery embolization