Prostatic Artery Embolization in Advanced Prostate Cancer

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

Detailed Description
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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.

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

Conditions
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Prostate Cancer, Bladder Outlet Obstruction

Intervention / Treatment
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* Device: Prostatic Artery Embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Advanced PCA (i.e., locally advanced, metastatic, combination of both. This includes T3-4, any T in case of N1 and any T in case of M1a/b/c) PAE is indicated for the treatment of Lower urinary tract symptoms like bladder outlet obstruction or recurrent prostatic bleeding. IPSS at baseline ≥ 8 Witten informed consent Exclusion Criteria: Curative treatment of PCA intended Contraindications for MRI Renal impairment (GFR < 30ml/min) Allergy to i.v. contrast medium Vascular conditions that seem to make successful PAE impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels) Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. Drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to PAE.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prostatic Artery Embolization (PAE)<br>PAE performed under local anesthesia using officially approved microspheres. | Device: Prostatic Artery Embolization<br>* PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Lower Urinary Tract Symptoms | Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms)) | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Lower Urinary Tract Symptoms | Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms)) | Baseline and 6 weeks | 
| Reduction of Lower Urinary Tract Symptoms | Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms)) | Baseline and 6 months | 
| Reduction of Lower Urinary Tract Symptoms | Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms)) | Baseline and 12 months | 
| Occurrence of macroscopic hematuria | Assessment of occurrence of hematuria according to CTCAE v.4.03 classification | From time of PAE to study completion (1 year) | 
| Reduction of Prostate symptoms | Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms)) | baseline and 6 weeks | 
| Reduction of Prostate symptoms | Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms)) | baseline and 12 weeks | 
| Reduction of Prostate symptoms | Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms)) | baseline and 6 months | 
| Reduction of Prostate symptoms | Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms)) | baseline and 12 months | 
| Occurrence of urinary incontinence | Assessment of ICS-SF questionnaire | 6 week after PAE | 
| Occurrence of urinary incontinence | Assessment of ICS-SF questionnaire | 12 week after PAE | 
| Occurrence of urinary incontinence | Assessment of ICS-SF questionnaire | 6 months after PAE | 
| Occurrence of urinary incontinence | Assessment of ICS-SF questionnaire | 12 months after PAE | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | Baseline and 6 weeks | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | Baseline and 12 weeks | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | Baseline and 6 months | 
| Changes of free urinary flow rate | Measurement of urinary stream (mL/s) by urinary flow rate measurement | Baseline and 12 months | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | Baseline and 6 weeks | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | Baseline and 12 weeks | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | Baseline and 6 months | 
| Changes of post void residual urine | Measurement of post void residual urine (mL) by transabdominal ultrasound | Baseline and 12 months | 
| Rate of local reinterventions | Assessment of number and type of reinterventions for prostate and bladder problems | During 1 year study period | 
| Intraoperative Adverse Events | Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE | While PAE is performed (intra-operatively) | 
| Adverse Events | Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE | 6 weeks after PAE | 
| Adverse Events | Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE | 12 weeks after PAE | 
| Adverse Events | Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE | 6 months after PAE | 
| Adverse Events | Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE | 12 months after PAE | 
| Feasibility of PAE | Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate | While PAE is performed (intra-operatively) | 
| Estimation of tumor burden | Changes of Prostate Specific Antigen | Baseline and 24h after PAE | 
| Estimation of tumor burden | Changes of Prostate Specific Antigen | Baseline and 6 weeks after PAE | 
| Estimation of tumor burden | Changes of Prostate Specific Antigen | Baseline and 12 weeks after PAE | 
| Estimation of tumor burden | Changes of Prostate Specific Antigen | Baseline and 6 months after PAE | 
| Estimation of tumor burden | Changes of Prostate Specific Antigen | Baseline and 12 months after PAE | 
| Estimation of tumor volume | Change of tumor volume calculated by magnetic resonance imaging | Baseline and 12 weeks after PAE | 
| Prostate volume | Change of prostate volume calculated by magnetic resonance imaging | Baseline and 12 weeks after PAE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, prostate, embolization, minimally invasive, cytoreductive therapy