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

Sponsor
Dominik Abt (Other)
Overall Status
Completed
CT.gov ID
NCT02917161
Collaborator
(none)
12
Enrollment
2
Locations
1
Arm
11
Duration (Months)
6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Prostatic Artery Embolization (PAE)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Aug 3, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Tumor response [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.

Secondary Outcome Measures

  1. Histological Tumor Regression Grade [6 weeks after PAE (at the time of RALP)]

  2. Surgical margins assessment (R0 /R1) [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.

  3. Assessment of Adverse Events of PAE according to CTCAE V4.03 [At the time of PAE and 6 weeks afterwards]

  4. Assessment of Adverse Events of PAE according to Clavien-Dindo classification [At the time of PAE and 6 weeks afterwards]

  5. Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03 [At the time of RALP, 6 weeks and 12 weeks later]

  6. Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification [At the time of RALP, 6 weeks and 12 weeks later]

  7. Change of prostate volume in MRI after PAE [Before and 6 weeks after PAE]

  8. Change of tumor detection rate in MRI after PAE [Before and 6 weeks after PAE]

  9. Change of tumor size in MRI after PAE [Before and 6 weeks after PAE]

  10. Change of PIRADS classification in MRI after PAE [Before and 6 weeks after PAE]

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cantonal Hospital Lucerne, Department of Urology Lucerne Switzerland 6000
2 Urological Department, Cantonal Hospital of St. Gallen St. Gallen Switzerland 9007

Sponsors and Collaborators

  • Dominik Abt

Investigators

  • Principal Investigator: Dominik Abt, MD, Cantonal Hospital St. Gallen
  • Principal Investigator: Livio Mordasini, MD, Cantonal Hospital Luzerne

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dominik Abt, Dr. med., Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier:
NCT02917161
Other Study ID Numbers:
  • CTU 15/015
First Posted:
Sep 28, 2016
Last Update Posted:
Aug 9, 2017
Last Verified:
Aug 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Dominik Abt, Dr. med., Cantonal Hospital of St. Gallen
Prostate
Prostatic Neoplams
Therapeutic Embolization
Prostatectomy
Additional relevant MeSH terms:
Prostatic Neoplasms

Study Results

No Results Posted as of Aug 9, 2017