NCT03457805

Brief Summary

This is a pilot study assessing efficacy and safety in patients with advanced prostate cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable prostate-cancer

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 22, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

March 2, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

3.3 years

First QC Date

February 22, 2018

Last Update Submit

January 25, 2021

Conditions

Prostate CancerBladder Outlet Obstruction

Keywords

prostate cancerprostateembolizationminimally invasivecytoreductive therapy

Outcome Measures

Primary Outcomes (1)

  • Reduction of Lower Urinary Tract Symptoms

    Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))

    Baseline and 12 weeks

Secondary Outcomes (34)

  • Reduction of Lower Urinary Tract Symptoms

    Baseline and 6 weeks

  • Reduction of Lower Urinary Tract Symptoms

    Baseline and 6 months

  • Reduction of Lower Urinary Tract Symptoms

    Baseline and 12 months

  • Occurrence of macroscopic hematuria

    From time of PAE to study completion (1 year)

  • Reduction of Prostate symptoms

    baseline and 6 weeks

  • +29 more secondary outcomes

Study Arms (1)

Prostatic Artery Embolization (PAE)

OTHER

PAE performed under local anesthesia using officially approved microspheres.

Device: Prostatic Artery Embolization

Interventions

Prostatic Artery EmbolizationDEVICE

PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).

Prostatic Artery Embolization (PAE)

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced PCA (i.e., locally advanced, metastatic, combination of both. This includes T3-4, any T in case of N1 and any T in case of M1a/b/c)
  • PAE is indicated for the treatment of Lower urinary tract symptoms like bladder outlet obstruction or recurrent prostatic bleeding.
  • IPSS at baseline ≥ 8
  • Witten informed consent

You may not qualify if:

  • Curative treatment of PCA intended
  • Contraindications for MRI
  • Renal impairment (GFR \< 30ml/min)
  • Allergy to i.v. contrast medium
  • Vascular conditions that seem to make successful PAE impossible (e.g. severe atherosclerosis, severe tortuosity in the aortic bifurcation or internal iliac vessels)
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
  • Drug-treatments for advanced prostate cancer (e.g., hormonal therapy or chemotherapy) established within 30 days prior to PAE.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

Related Publications (1)

  • Burkhardt O, Abt D, Hechelhammer L, Kim O, Omlin A, Schmid HP, Engeler D, Zumstein V, Mullhaupt G. Prostatic Artery Embolization in Patients with Advanced Prostate Cancer: A Prospective Single Center Pilot Study. Cardiovasc Intervent Radiol. 2024 Jun;47(6):771-782. doi: 10.1007/s00270-024-03679-z. Epub 2024 Feb 28.

    PMID: 38416176DERIVED

MeSH Terms

Conditions

Prostatic NeoplasmsUrinary Bladder Neck Obstruction

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesUrethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrinary Bladder Diseases

Study Officials

  • Dominik Abt, MD

    St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominik Abt, MD

CONTACT

+41714941418dominik.abt@kssg.ch

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

February 22, 2018

First Posted

March 8, 2018

Study Start

March 2, 2018

Primary Completion

July 2, 2021

Study Completion

August 2, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Locations

CH(1)