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Procedure
Prostatic Artery Embolization for Lower Urinary Tract Symptoms Due to Prostate Cancer
N/A
Recruiting
Led By Andrew Picel, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prostate volume ≥ 40 mL and ≤ 300 mL
Age ≥ 40 years and ≤ 90 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, 2 months, and 12 months after intervention
Awards & highlights
Study Summary
This trial will test if prostatic artery embolization, a minimally invasive procedure, can help relieve urinary symptoms in patients with an enlarged prostate or prostate cancer.
Who is the study for?
Men aged 40-90 with biopsy-proven prostate cancer receiving radiation therapy and suffering from moderate to severe urinary symptoms due to an enlarged prostate can join. They must have a certain level of urine flow, specific prostate volume, and quality of life score. Those with other urogenital cancers, non-prostate related urinary issues, allergies to contrast agents not managed by steroids, large bladder stones or diverticula, untreated blood clotting problems or neurogenic bladder disorders cannot participate.Check my eligibility
What is being tested?
The trial is testing if prostatic artery embolization—a procedure that blocks blood flow to parts of the prostate—can help reduce urinary tract symptoms in men who are undergoing radiation therapy for their enlarged prostates due to cancer.See study design
What are the potential side effects?
Potential side effects may include discomfort at the catheter insertion site, minor bleeding or bruising there as well. There could also be risks associated with exposure to X-rays used during the procedure and possible allergic reactions to the contrast dye used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate size is between 40 and 300 mL.
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I am between 40 and 90 years old.
Select...
I have prostate cancer confirmed by biopsy and am receiving radiation therapy.
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My quality of life score is 3 or higher.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, 2 months, and 12 months after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, 2 months, and 12 months after intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline in symptom score using the International Prostate Symptom Scale (IPSS)
Secondary outcome measures
Mean change from baseline in international prostate symptom scale to measure long term subjective outcomes measured
Mean change from baseline in maximal urinary flow measured
Mean change from baseline in post-void residual measured
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Prostatic artery embolization (PAE)Experimental Treatment1 Intervention
Study participants will be treated with a single PAE procedure performed with Embosphere microspheres.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prostatic artery embolization
2014
N/A
~110
Find a Location
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,345 Total Patients Enrolled
22 Trials studying Prostate Cancer
3,976 Patients Enrolled for Prostate Cancer
Andrew Picel, MDPrincipal InvestigatorStanford University
2 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood clotting issue cannot be corrected with medication.Your urine flow rate is less than 12 milliliters per second.My prostate size is between 40 and 300 mL.I have moderate to severe symptoms related to my lower urinary tract.My bladder muscle doesn't work properly, or I have a blockage in my urinary tract not caused by prostate issues.I have a large bladder pouch or large bladder stones.I am between 40 and 90 years old.Your blood test shows that your creatinine level is higher than 2 mg/dL before starting the study.I do not have any other active cancers in my urinary or genital organs.I have prostate cancer confirmed by biopsy and am receiving radiation therapy.You are allergic to iodinated contrast agents and steroids don't help with the allergy.You have a high score on a test for urinary problems, or you need a urinary catheter.My quality of life score is 3 or higher.Your blood vessels are twisted or have signs of blockage from cholesterol buildup.My bladder issues are due to a condition like MS, Parkinson's, spinal injury, or diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Prostatic artery embolization (PAE)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the participant age range of this clinical trial greater than 25 years old?
"This clinical trial seeks out participants aged between 40 and 90 years old."
Answered by AI
Is the research team currently accepting participants for this study?
"This research initiative, first posted on the 1st of January 2023 and last updated on November 9th 2022, is not actively recruiting patients. However, 1356 other medical studies are open for enrollment presently."
Answered by AI
What hazards should be taken into account when administering this treatment?
"The safety of this treatment can be estimated at a 1 as it is currently in Phase 1, which indicates that there is sparse evidence backing its efficacy and limited data verifying its safety."
Answered by AI
What criteria are required to qualify for participation in this research?
"This trial calls for 10 volunteers, aged 40 to 90 years old, suffering from prostate cancer. To be eligible for the study, participants must have a prostate volume between 40 mL and 300 mL; biopsy-confirmed prostate cancer; an International Prostate Symptom Score (IPSS) of at least 12 or one requiring urinary catheterization with an IPSS Quality of Life assessment score that exceeds 3; maximum urine flow rate not surpassing 12mL/sec; and the capacity to comprehend the consent form while voluntarily agreeing to it."
Answered by AI
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