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

August 8, 2017 updated by: Dominik Abt

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lucerne, Switzerland, 6000
        • Cantonal Hospital Lucerne, Department of Urology
      • St. Gallen, Switzerland, 9007
        • Urological Department, Cantonal Hospital of St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prostatic Artery Embolization (PAE)
PAE is performed 6weeks before RALP
Device: Prostatic Artery Embolization (PAE)
PAE is performed 6 weeks before radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response
Time Frame: 6 weeks after PAE (at the time of RALP)
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
Time Frame: 6 weeks after PAE (at the time of RALP)
6 weeks after PAE (at the time of RALP)
Surgical margins assessment (R0 /R1)
Time Frame: 6 weeks after PAE (at the time of RALP)
- 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
Time Frame: At the time of PAE and 6 weeks afterwards
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
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
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
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
Before and 6 weeks after PAE
Change of tumor detection rate in MRI after PAE
Time Frame: Before and 6 weeks after PAE
Before and 6 weeks after PAE
Change of tumor size in MRI after PAE
Time Frame: Before and 6 weeks after PAE
Before and 6 weeks after PAE
Change of PIRADS classification in MRI after PAE
Time Frame: Before and 6 weeks after PAE
Before and 6 weeks after PAE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dominik Abt

Investigators

  • Principal Investigator: Livio Mordasini, MD, Cantonal Hospital Luzerne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

August 3, 2017

Study Registration Dates

First Submitted

September 24, 2016

First Submitted That Met QC Criteria

September 26, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTU 15/015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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