Prostatic Artery Embolization in Advanced Prostate Cancer
- Conditions
- Bladder Outlet ObstructionProstate Cancer
- Interventions
- Device: Prostatic Artery Embolization
- Registration Number
- NCT03457805
- Lead Sponsor
- Dominik Abt
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 20
Not provided
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prostatic Artery Embolization (PAE) Prostatic Artery Embolization PAE performed under local anesthesia using officially approved microspheres.
- Primary Outcome Measures
Name Time Method Reduction of Lower Urinary Tract Symptoms Baseline and 12 weeks Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
- Secondary Outcome Measures
Name Time Method Occurrence of urinary incontinence 12 months after PAE Assessment of ICS-SF questionnaire
Reduction of Lower Urinary Tract Symptoms Baseline and 12 months Change of total score of International Prostate Symptoms Score (IPSS; range 0 points (no symptoms) to 35 points (severe symptoms))
Reduction of Prostate symptoms baseline and 12 months Change of CPSI total score (Chronic prostatitis symptoms score; range 0 points (no symptoms) to 43 points (severe symptoms))
Changes of free urinary flow rate Baseline and 12 months Measurement of urinary stream (mL/s) by urinary flow rate measurement
Adverse Events 12 months after PAE Assessment of adverse events that are at least possibly related to study procedure according to Clavien-Dindo and CTCAE
Occurrence of macroscopic hematuria From time of PAE to study completion (1 year) Assessment of occurrence of hematuria according to CTCAE v.4.03 classification
Intraoperative Adverse Events 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
Prostate volume Baseline and 12 weeks after PAE Change of prostate volume calculated by magnetic resonance imaging
Changes of post void residual urine Baseline and 12 months Measurement of post void residual urine (mL) by transabdominal ultrasound
Feasibility of PAE 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
Rate of local reinterventions During 1 year study period Assessment of number and type of reinterventions for prostate and bladder problems
Estimation of tumor burden Baseline and 12 months after PAE Changes of Prostate Specific Antigen
Estimation of tumor volume Baseline and 12 weeks after PAE Change of tumor volume calculated by magnetic resonance imaging
Trial Locations
- Locations (1)
Cantonal Hospital St. Gallen
🇨ðŸ‡St. Gallen, Saint Gallen, Switzerland