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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Prostatic Artery Embolization (PAE)
Sponsored by
Dominik Abt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate, Prostatic Neoplams, Therapeutic Embolization, Prostatectomy

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostatic Artery Embolization (PAE)

Arm Description

PAE is performed 6weeks before RALP

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Histological Tumor Regression Grade
Surgical margins assessment (R0 /R1)
- Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins.
Assessment of Adverse Events of PAE according to CTCAE V4.03
Assessment of Adverse Events of PAE according to Clavien-Dindo classification
Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03
Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification
Change of prostate volume in MRI after PAE
Change of tumor detection rate in MRI after PAE
Change of tumor size in MRI after PAE
Change of PIRADS classification in MRI after PAE

Full Information

First Posted
September 24, 2016
Last Updated
August 8, 2017
Sponsor
Dominik Abt
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1. Study Identification

Unique Protocol Identification Number
NCT02917161
Brief Title
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
Official Title
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
August 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dominik Abt

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate, Prostatic Neoplams, Therapeutic Embolization, Prostatectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prostatic Artery Embolization (PAE)
Arm Type
Experimental
Arm Description
PAE is performed 6weeks before RALP
Intervention Type
Device
Intervention Name(s)
Prostatic Artery Embolization (PAE)
Intervention Description
PAE is performed 6 weeks before radical prostatectomy
Primary Outcome Measure Information:
Title
Tumor response
Description
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 Outcome Measure Information:
Title
Histological Tumor Regression Grade
Time Frame
6 weeks after PAE (at the time of RALP)
Title
Surgical margins assessment (R0 /R1)
Description
- 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)
Title
Assessment of Adverse Events of PAE according to CTCAE V4.03
Time Frame
At the time of PAE and 6 weeks afterwards
Title
Assessment of Adverse Events of PAE according to Clavien-Dindo classification
Time Frame
At the time of PAE and 6 weeks afterwards
Title
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
Title
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
Title
Change of prostate volume in MRI after PAE
Time Frame
Before and 6 weeks after PAE
Title
Change of tumor detection rate in MRI after PAE
Time Frame
Before and 6 weeks after PAE
Title
Change of tumor size in MRI after PAE
Time Frame
Before and 6 weeks after PAE
Title
Change of PIRADS classification in MRI after PAE
Time Frame
Before and 6 weeks after PAE

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Abt, MD
Organizational Affiliation
Cantonal Hospital St. Gallen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Livio Mordasini, MD
Organizational Affiliation
Cantonal Hospital Luzerne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital Lucerne, Department of Urology
City
Lucerne
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Urological Department, Cantonal Hospital of St. Gallen
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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