Prostatic Artery Embolization in Advanced Prostate Cancer

Dominik Abt20 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer Bladder Outlet Obstruction

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).

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

Cantonal Hospital St. Gallen

Sankt Gallen, Canton of St. Gallen, Switzerland

RECRUITING

Outcomes

Primary Outcomes

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))

Time frame: Baseline and 12 weeks

Secondary Outcomes

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))

Time frame: 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))

Time frame: 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))

Time frame: Baseline and 12 months

Occurrence of macroscopic hematuria

Assessment of occurrence of hematuria according to CTCAE v.4.03 classification

Time frame: 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))

Time frame: 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))

Central Contacts

Dominik Abt, MD

CONTACT

+41714941418 dominik.abt@kssg.ch

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time frame: 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))

Time frame: 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))

Time frame: baseline and 12 months

Occurrence of urinary incontinence

Assessment of ICS-SF questionnaire

Time frame: 6 week after PAE

Occurrence of urinary incontinence

Assessment of ICS-SF questionnaire

Time frame: 12 week after PAE

Occurrence of urinary incontinence

Assessment of ICS-SF questionnaire

Time frame: 6 months after PAE

Occurrence of urinary incontinence

Assessment of ICS-SF questionnaire

Time frame: 12 months after PAE

Changes of free urinary flow rate

Measurement of urinary stream (mL/s) by urinary flow rate measurement

Time frame: Baseline and 6 weeks

Changes of free urinary flow rate

Measurement of urinary stream (mL/s) by urinary flow rate measurement

Time frame: Baseline and 12 weeks

Changes of free urinary flow rate

Measurement of urinary stream (mL/s) by urinary flow rate measurement

Time frame: Baseline and 6 months

Changes of free urinary flow rate

Measurement of urinary stream (mL/s) by urinary flow rate measurement

Time frame: Baseline and 12 months

Changes of post void residual urine

Measurement of post void residual urine (mL) by transabdominal ultrasound

Time frame: Baseline and 6 weeks

Changes of post void residual urine

Measurement of post void residual urine (mL) by transabdominal ultrasound

Time frame: Baseline and 12 weeks

Changes of post void residual urine

Measurement of post void residual urine (mL) by transabdominal ultrasound

Time frame: Baseline and 6 months

Changes of post void residual urine

Measurement of post void residual urine (mL) by transabdominal ultrasound

Time frame: Baseline and 12 months

Rate of local reinterventions

Assessment of number and type of reinterventions for prostate and bladder problems

Time frame: During 1 year study period

Intraoperative Adverse Events