Prostatic Artery Embolization in Advanced Prostate Cancer

January 25, 2021 updated by: Dominik Abt

Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PAE has been shown to be safe and effective in the treatment of prostatic bleeding and lower urinary tract symptoms arising from bladder outlet obstruction.

Advanced (defined as locally advanced, metastatic or both in this study) PCA is frequently associated with both of these conditions. The currently most frequently performed palliative surgical treatment is TURP. Though performed endoscopically, TURP is associated with significant side effects in this setting. PAE has been shown to have a superior side-effect profile in the treatment of bladder outlet obstruction compared to TURP.

In addition, there is growing evidence that patients with advanced PCA might benefit from cytoreductive therapy (e.g. radical prostatectomy or external beam radiation therapy). However, recent methods of cytoreductive treatment of PCA hold the risk of being highly invasive and are associated with severe side effects. PAE might represent a minimally invasive alternative in this setting.

Therefore, efficacy and safety of PAE in patients with advanced prostate cancer is assessed in this pilot-study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • Saint Gallen
      • St. Gallen, Saint Gallen, Switzerland, 9007

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Prostatic Artery Embolization (PAE)
PAE performed under local anesthesia using officially approved microspheres.
Device: Prostatic Artery Embolization
PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction of Lower Urinary Tract Symptoms
Time Frame: Baseline and 12 weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reduction of Lower Urinary Tract Symptoms
Time Frame: Baseline and 6 weeks
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Baseline and 6 weeks
Reduction of Lower Urinary Tract Symptoms
Time Frame: Baseline and 6 months
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Baseline and 6 months
Reduction of Lower Urinary Tract Symptoms
Time Frame: Baseline and 12 months
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Baseline and 12 months
Occurrence of macroscopic hematuria
Time Frame: From time of PAE to study completion (1 year)
Assessment of occurrence of hematuria according to CTCAE v.4.03 classification
From time of PAE to study completion (1 year)
Reduction of Prostate symptoms
Time Frame: baseline and 6 weeks
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
baseline and 6 weeks
Reduction of Prostate symptoms
Time Frame: baseline and 12 weeks
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
baseline and 12 weeks
Reduction of Prostate symptoms
Time Frame: baseline and 6 months
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
baseline and 6 months
Reduction of Prostate symptoms
Time Frame: baseline and 12 months
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
baseline and 12 months
Occurrence of urinary incontinence
Time Frame: 6 week after PAE
Assessment of ICS-SF questionnaire
6 week after PAE
Occurrence of urinary incontinence
Time Frame: 12 week after PAE
Assessment of ICS-SF questionnaire
12 week after PAE
Occurrence of urinary incontinence
Time Frame: 6 months after PAE
Assessment of ICS-SF questionnaire
6 months after PAE
Occurrence of urinary incontinence
Time Frame: 12 months after PAE
Assessment of ICS-SF questionnaire
12 months after PAE
Changes of free urinary flow rate
Time Frame: Baseline and 6 weeks
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Baseline and 6 weeks
Changes of free urinary flow rate
Time Frame: Baseline and 12 weeks
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Baseline and 12 weeks
Changes of free urinary flow rate
Time Frame: Baseline and 6 months
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Baseline and 6 months
Changes of free urinary flow rate
Time Frame: Baseline and 12 months
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Baseline and 12 months
Changes of post void residual urine
Time Frame: Baseline and 6 weeks
Measurement of post void residual urine (mL) by transabdominal ultrasound
Baseline and 6 weeks
Changes of post void residual urine
Time Frame: Baseline and 12 weeks
Measurement of post void residual urine (mL) by transabdominal ultrasound
Baseline and 12 weeks
Changes of post void residual urine
Time Frame: Baseline and 6 months
Measurement of post void residual urine (mL) by transabdominal ultrasound
Baseline and 6 months
Changes of post void residual urine
Time Frame: Baseline and 12 months
Measurement of post void residual urine (mL) by transabdominal ultrasound
Baseline and 12 months
Rate of local reinterventions
Time Frame: During 1 year study period
Assessment of number and type of reinterventions for prostate and bladder problems
During 1 year study period
Intraoperative Adverse Events
Time Frame: While PAE is performed (intra-operatively)
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
While PAE is performed (intra-operatively)
Adverse Events
Time Frame: 6 weeks after PAE
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
6 weeks after PAE
Adverse Events
Time Frame: 12 weeks after PAE
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
12 weeks after PAE
Adverse Events
Time Frame: 6 months after PAE
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
6 months after PAE
Adverse Events
Time Frame: 12 months after PAE
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
12 months after PAE
Feasibility of PAE
Time Frame: While PAE is performed (intra-operatively)
Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate
While PAE is performed (intra-operatively)
Estimation of tumor burden
Time Frame: Baseline and 24h after PAE
Changes of Prostate Specific Antigen
Baseline and 24h after PAE
Estimation of tumor burden
Time Frame: Baseline and 6 weeks after PAE
Changes of Prostate Specific Antigen
Baseline and 6 weeks after PAE
Estimation of tumor burden
Time Frame: Baseline and 12 weeks after PAE
Changes of Prostate Specific Antigen
Baseline and 12 weeks after PAE
Estimation of tumor burden
Time Frame: Baseline and 6 months after PAE
Changes of Prostate Specific Antigen
Baseline and 6 months after PAE
Estimation of tumor burden
Time Frame: Baseline and 12 months after PAE
Changes of Prostate Specific Antigen
Baseline and 12 months after PAE
Estimation of tumor volume
Time Frame: Baseline and 12 weeks after PAE
Change of tumor volume calculated by magnetic resonance imaging
Baseline and 12 weeks after PAE
Prostate volume
Time Frame: Baseline and 12 weeks after PAE
Change of prostate volume calculated by magnetic resonance imaging
Baseline and 12 weeks after PAE

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dominik Abt

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dominik Abt, MD, St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTU17/028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Decision will be made individually up on request and based on approval by our local ethics committee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on Prostate Cancer

Clinical Trials on Prostatic Artery Embolization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings