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

NCT ID: NCT02917161

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-08-03

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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prostatic Artery Embolization (PAE)

PAE is performed 6weeks before RALP

Group Type EXPERIMENTAL

Prostatic Artery Embolization (PAE)

Intervention Type DEVICE

PAE is performed 6 weeks before radical prostatectomy

Interventions

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Prostatic Artery Embolization (PAE)

PAE is performed 6 weeks before radical prostatectomy

Intervention Type DEVICE

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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dominik Abt

OTHER

Sponsor Role lead

Responsible Party

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Dominik Abt

Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dominik Abt, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital St. Gallen

Livio Mordasini, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital Luzerne

Locations

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Cantonal Hospital Lucerne, Department of Urology

Lucerne, , Switzerland

Site Status

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CTU 15/015

Identifier Type: -

Identifier Source: org_study_id

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