Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study

Study Overview
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Brief Summary
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MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer. This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

Detailed Description
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MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer. This proof of concept study assess the impact of PAE in patients with proven prostate cancer. PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer. The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.

Official Title
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Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Prostatic Artery Embolization (PAE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men 45 - 75 years old undergoing RALP Patient has biopsy-proven prostate adenocarcinoma Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings Written informed consent Exclusion Criteria: Severe atherosclerosis Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries Tumor stage > cT2 assessed by clinical and MRI findings Allergy to intravenous contrast media Contraindication for MRI imaging Renal failure (GFR<60ml/min) History of pelvic irradiation or radical pelvic surgery

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

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 |
| --- | --- |
| Experimental: Prostatic Artery Embolization (PAE)<br>PAE is performed 6weeks before RALP | Device: Prostatic Artery Embolization (PAE)<br>* PAE is performed 6 weeks before radical prostatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response | Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate. | 6 weeks after PAE (at the time of RALP) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological Tumor Regression Grade |  | 6 weeks after PAE (at the time of RALP) | 
| Surgical margins assessment (R0 /R1) | - Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins. | 6 weeks after PAE (at the time of RALP) | 
| Assessment of Adverse Events of PAE according to CTCAE V4.03 |  | At the time of PAE and 6 weeks afterwards | 
| Assessment of Adverse Events of PAE according to Clavien-Dindo classification |  | At the time of PAE and 6 weeks afterwards | 
| Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03 |  | At the time of RALP, 6 weeks and 12 weeks later | 
| Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification |  | At the time of RALP, 6 weeks and 12 weeks later | 
| Change of prostate volume in MRI after PAE |  | Before and 6 weeks after PAE | 
| Change of tumor detection rate in MRI after PAE |  | Before and 6 weeks after PAE | 
| Change of tumor size in MRI after PAE |  | Before and 6 weeks after PAE | 
| Change of PIRADS classification in MRI after PAE |  | Before and 6 weeks after PAE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate, Prostatic Neoplams, Therapeutic Embolization, Prostatectomy