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Prostatic Artery Embolization in Advanced Prostate Cancer

Primary Purpose

Prostate Cancer, Bladder Outlet Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Prostatic Artery Embolization
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 cancer, prostate, embolization, minimally invasive, cytoreductive therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Cantonal Hospital St. GallenRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Prostatic Artery Embolization (PAE)

Arm Description

PAE performed under local anesthesia using officially approved microspheres.

Outcomes

Primary Outcome Measures

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))

Secondary Outcome Measures

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))
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))
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))
Occurrence of macroscopic hematuria
Assessment of occurrence of hematuria according to CTCAE v.4.03 classification
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Reduction of Prostate symptoms
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Occurrence of urinary incontinence
Assessment of ICS-SF questionnaire
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Changes of free urinary flow rate
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Changes of post void residual urine
Measurement of post void residual urine (mL) by transabdominal ultrasound
Rate of local reinterventions
Assessment of number and type of reinterventions for prostate and bladder problems
Intraoperative Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Adverse Events
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Feasibility of PAE
Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate
Estimation of tumor burden
Changes of Prostate Specific Antigen
Estimation of tumor burden
Changes of Prostate Specific Antigen
Estimation of tumor burden
Changes of Prostate Specific Antigen
Estimation of tumor burden
Changes of Prostate Specific Antigen
Estimation of tumor burden
Changes of Prostate Specific Antigen
Estimation of tumor volume
Change of tumor volume calculated by magnetic resonance imaging
Prostate volume
Change of prostate volume calculated by magnetic resonance imaging

Full Information

First Posted
February 22, 2018
Last Updated
January 25, 2021
Sponsor
Dominik Abt
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1. Study Identification

Unique Protocol Identification Number
NCT03457805
Brief Title
Prostatic Artery Embolization in Advanced Prostate Cancer
Official Title
Prostatic Artery Embolization (PAE) in Patients With Advanced Prostate Cancer: A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
July 2, 2021 (Anticipated)
Study Completion Date
August 2, 2021 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Bladder Outlet Obstruction
Keywords
prostate cancer, prostate, embolization, minimally invasive, cytoreductive therapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Prostatic Artery Embolization (PAE)
Arm Type
Other
Arm Description
PAE performed under local anesthesia using officially approved microspheres.
Intervention Type
Device
Intervention Name(s)
Prostatic Artery Embolization
Intervention Description
PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).
Primary Outcome Measure Information:
Title
Reduction of Lower Urinary Tract Symptoms
Description
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Reduction of Lower Urinary Tract Symptoms
Description
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time Frame
Baseline and 6 weeks
Title
Reduction of Lower Urinary Tract Symptoms
Description
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time Frame
Baseline and 6 months
Title
Reduction of Lower Urinary Tract Symptoms
Description
Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Time Frame
Baseline and 12 months
Title
Occurrence of macroscopic hematuria
Description
Assessment of occurrence of hematuria according to CTCAE v.4.03 classification
Time Frame
From time of PAE to study completion (1 year)
Title
Reduction of Prostate symptoms
Description
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time Frame
baseline and 6 weeks
Title
Reduction of Prostate symptoms
Description
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time Frame
baseline and 12 weeks
Title
Reduction of Prostate symptoms
Description
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time Frame
baseline and 6 months
Title
Reduction of Prostate symptoms
Description
Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Time Frame
baseline and 12 months
Title
Occurrence of urinary incontinence
Description
Assessment of ICS-SF questionnaire
Time Frame
6 week after PAE
Title
Occurrence of urinary incontinence
Description
Assessment of ICS-SF questionnaire
Time Frame
12 week after PAE
Title
Occurrence of urinary incontinence
Description
Assessment of ICS-SF questionnaire
Time Frame
6 months after PAE
Title
Occurrence of urinary incontinence
Description
Assessment of ICS-SF questionnaire
Time Frame
12 months after PAE
Title
Changes of free urinary flow rate
Description
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time Frame
Baseline and 6 weeks
Title
Changes of free urinary flow rate
Description
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time Frame
Baseline and 12 weeks
Title
Changes of free urinary flow rate
Description
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time Frame
Baseline and 6 months
Title
Changes of free urinary flow rate
Description
Measurement of urinary stream (mL/s) by urinary flow rate measurement
Time Frame
Baseline and 12 months
Title
Changes of post void residual urine
Description
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time Frame
Baseline and 6 weeks
Title
Changes of post void residual urine
Description
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time Frame
Baseline and 12 weeks
Title
Changes of post void residual urine
Description
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time Frame
Baseline and 6 months
Title
Changes of post void residual urine
Description
Measurement of post void residual urine (mL) by transabdominal ultrasound
Time Frame
Baseline and 12 months
Title
Rate of local reinterventions
Description
Assessment of number and type of reinterventions for prostate and bladder problems
Time Frame
During 1 year study period
Title
Intraoperative Adverse Events
Description
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time Frame
While PAE is performed (intra-operatively)
Title
Adverse Events
Description
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time Frame
6 weeks after PAE
Title
Adverse Events
Description
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time Frame
12 weeks after PAE
Title
Adverse Events
Description
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time Frame
6 months after PAE
Title
Adverse Events
Description
Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Time Frame
12 months after PAE
Title
Feasibility of PAE
Description
Possibility of successful completion of PAE in the study cohort defined by compete stasis of blood flow in the prostate
Time Frame
While PAE is performed (intra-operatively)
Title
Estimation of tumor burden
Description
Changes of Prostate Specific Antigen
Time Frame
Baseline and 24h after PAE
Title
Estimation of tumor burden
Description
Changes of Prostate Specific Antigen
Time Frame
Baseline and 6 weeks after PAE
Title
Estimation of tumor burden
Description
Changes of Prostate Specific Antigen
Time Frame
Baseline and 12 weeks after PAE
Title
Estimation of tumor burden
Description
Changes of Prostate Specific Antigen
Time Frame
Baseline and 6 months after PAE
Title
Estimation of tumor burden
Description
Changes of Prostate Specific Antigen
Time Frame
Baseline and 12 months after PAE
Title
Estimation of tumor volume
Description
Change of tumor volume calculated by magnetic resonance imaging
Time Frame
Baseline and 12 weeks after PAE
Title
Prostate volume
Description
Change of prostate volume calculated by magnetic resonance imaging
Time Frame
Baseline and 12 weeks after PAE

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominik Abt, MD
Phone
+41714941418
Email
dominik.abt@kssg.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominik Abt, MD
Organizational Affiliation
St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cantonal Hospital St. Gallen
City
St. Gallen
State/Province
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominik Abt, MD
Phone
+41714941416
Email
dominik.abt@kssg.ch
First Name & Middle Initial & Last Name & Degree
Gautier Müllhaupt, MD
Phone
+41714941416
Email
Gautier.muellhaupt@kssg.ch

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Decision will be made individually up on request and based on approval by our local ethics committee.

Learn more about this trial

Prostatic Artery Embolization in Advanced Prostate Cancer

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