Prostatic Artery Embolization in Advanced Prostate Cancer

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: Recruiting
• Conditions: Prostate Cancer; Bladder Outlet Obstruction
• Intervention / Treatment: Device: Prostatic Artery Embolization

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: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dominik Abt, MD; Phone Number: +41714941418; Email: dominik.abt@kssg.ch

Study Locations

• Switzerland
  • Saint Gallen
    • St. Gallen, Saint Gallen, Switzerland, 9007
      • Recruiting
      • Cantonal Hospital St. Gallen
      • Contact: Dominik Abt, MD; Phone Number: +41714941416; Email: dominik.abt@kssg.ch
      • Contact: Gautier Müllhaupt, MD; Phone Number: +41714941416; Email: Gautier.muellhaupt@kssg.ch

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 6 weeks
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 6 months
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 months
Occurrence of macroscopic hematuria	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	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	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	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	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	Assessment of ICS-SF questionnaire	6 week after PAE
Occurrence of urinary incontinence	Assessment of ICS-SF questionnaire	12 week after PAE
Occurrence of urinary incontinence	Assessment of ICS-SF questionnaire	6 months after PAE
Occurrence of urinary incontinence	Assessment of ICS-SF questionnaire	12 months after PAE
Changes of free urinary flow rate	Measurement of urinary stream (mL/s) by urinary flow rate measurement	Baseline and 6 weeks
Changes of free urinary flow rate	Measurement of urinary stream (mL/s) by urinary flow rate measurement	Baseline and 12 weeks
Changes of free urinary flow rate	Measurement of urinary stream (mL/s) by urinary flow rate measurement	Baseline and 6 months
Changes of free urinary flow rate	Measurement of urinary stream (mL/s) by urinary flow rate measurement	Baseline and 12 months
Changes of post void residual urine	Measurement of post void residual urine (mL) by transabdominal ultrasound	Baseline and 6 weeks
Changes of post void residual urine	Measurement of post void residual urine (mL) by transabdominal ultrasound	Baseline and 12 weeks
Changes of post void residual urine	Measurement of post void residual urine (mL) by transabdominal ultrasound	Baseline and 6 months
Changes of post void residual urine	Measurement of post void residual urine (mL) by transabdominal ultrasound	Baseline and 12 months
Rate of local reinterventions	Assessment of number and type of reinterventions for prostate and bladder problems	During 1 year study period
Intraoperative Adverse Events	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	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	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	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	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	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	Changes of Prostate Specific Antigen	Baseline and 24h after PAE
Estimation of tumor burden	Changes of Prostate Specific Antigen	Baseline and 6 weeks after PAE
Estimation of tumor burden	Changes of Prostate Specific Antigen	Baseline and 12 weeks after PAE
Estimation of tumor burden	Changes of Prostate Specific Antigen	Baseline and 6 months after PAE
Estimation of tumor burden	Changes of Prostate Specific Antigen	Baseline and 12 months after PAE
Estimation of tumor volume	Change of tumor volume calculated by magnetic resonance imaging	Baseline and 12 weeks after PAE
Prostate volume	Change of prostate volume calculated by magnetic resonance imaging	Baseline and 12 weeks after PAE

Collaborators and Investigators

• Sponsor: Dominik Abt
• Investigators: Principal Investigator: Dominik Abt, MD, St. Gallen Cantonal Hospital, Dept. of Urology, Rorschacherstrasse 95, 9007 St. Gallen

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2018
• Primary Completion (Anticipated): July 2, 2021
• Study Completion (Anticipated): August 2, 2021

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 6, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 25, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: prostate cancer; prostate; embolization; minimally invasive; cytoreductive therapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Genital Neoplasms, Male; Prostatic Diseases; Urethral Diseases; Urethral Obstruction; Prostatic Neoplasms; Urinary Bladder Neck Obstruction
• Other Study ID 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