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

Dominik Abt12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

Prostatic Artery Embolization (PAE)DEVICE

PAE is performed 6 weeks before radical prostatectomy

Eligibility

Sex: MALEMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Cantonal Hospital Lucerne, Department of Urology

Lucerne, Switzerland

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, Switzerland

Outcomes

Primary Outcomes

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.

Time frame: 6 weeks after PAE (at the time of RALP)

Secondary Outcomes

Histological Tumor Regression Grade

Time frame: 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.

Time frame: 6 weeks after PAE (at the time of RALP)

Assessment of Adverse Events of PAE according to CTCAE V4.03

Time frame: At the time of PAE and 6 weeks afterwards

Assessment of Adverse Events of PAE according to Clavien-Dindo classification

Time frame: At the time of PAE and 6 weeks afterwards

Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03

Time frame: At the time of RALP, 6 weeks and 12 weeks later

Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification

Time frame: At the time of RALP, 6 weeks and 12 weeks later

Change of prostate volume in MRI after PAE

Time frame: Before and 6 weeks after PAE

Change of tumor detection rate in MRI after PAE

Data from ClinicalTrials.gov

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