Prostatic Artery Embolization in Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03457805
• Other study ID #: CTU17/028
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2018
• Est. completion date: August 2, 2021

Study information

• Verified date: January 2021
• Source: Cantonal Hospital of St. Gallen
• Contact: Dominik Abt, MD
• Phone: +41714941418
• Email: dominik.abt[@]kssg.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2, 2021
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Outlet Obstruction
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Bladder Neck Obstruction

Intervention

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).

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital St. Gallen	St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Dominik Abt

Country where clinical trial is conducted

Switzerland, 

Outcome

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