NCT02917161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

September 24, 2016

Last Update Submit

August 8, 2017

Conditions

Prostate Cancer

Keywords

ProstateProstatic NeoplamsTherapeutic EmbolizationProstatectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks after PAE (at the time of RALP)

Secondary Outcomes (10)

  • Histological Tumor Regression Grade

    6 weeks after PAE (at the time of RALP)

  • Surgical margins assessment (R0 /R1)

    6 weeks after PAE (at the time of RALP)

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

    At the time of PAE and 6 weeks afterwards

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

    At the time of PAE and 6 weeks afterwards

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

    At the time of RALP, 6 weeks and 12 weeks later

  • +5 more secondary outcomes

Study Arms (1)

Prostatic Artery Embolization (PAE)

EXPERIMENTAL

PAE is performed 6weeks before RALP

Device: Prostatic Artery Embolization (PAE)

Interventions

Prostatic Artery Embolization (PAE)DEVICE

PAE is performed 6 weeks before radical prostatectomy

Prostatic Artery Embolization (PAE)

Eligibility Criteria

Age45 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cantonal Hospital Lucerne, Department of Urology

Lucerne, 6000, Switzerland

Location

Urological Department, Cantonal Hospital of St. Gallen

Sankt Gallen, 9007, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Dominik Abt, MD

    Cantonal Hospital of St. Gallen

    PRINCIPAL INVESTIGATOR

  • Livio Mordasini, MD

    Cantonal Hospital Luzerne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

September 24, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

August 3, 2017

Last Updated

August 9, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(2)