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PAE + Radiation for Prostate Cancer
Phase 2
Recruiting
Led By Nainesh S Parikh, MD, MBA
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. Gleason Grade groups 1 and 2) who are eligible for and who select XRT as their cancer management method.
Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks
Awards & highlights
Study Summary
This trial is testing whether a new treatment for prostate cancer, called Prostatic Artery Embolization (PAE), is effective. PAE will be given to patients before they start radiation therapy. Patients will be followed for six and twelve weeks after PAE to see how well the treatment works.
Who is the study for?
Men with low to intermediate-risk prostate cancer who choose radiation therapy and have a prostate size between 60-150 grams. They must understand the study and consent to participate, have normal organ function, an AUA or IPSS Score of 15 or more, and be able to undergo PAE within 6-12 weeks before radiotherapy.Check my eligibility
What is being tested?
The trial is testing if Prostatic Artery Embolization (PAE) performed prior to radiation therapy can improve outcomes for patients with prostate cancer. Participants will receive PAE by Interventional Radiology followed by regular check-ups leading up to their definitive radiotherapy.See study design
What are the potential side effects?
Possible side effects include discomfort at the embolization site, minor bleeding, infection risk from catheter placement for PAE, fatigue from radiation therapy, as well as potential urinary issues related to both treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is low risk and I've chosen radiation therapy.
Select...
My prostate is between 60 and 150 grams in size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in International Prostate Symptom Score
Secondary outcome measures
Change in American Urologic Association Score
Prostate Volume Reduction after PAE
Trial Design
1Treatment groups
Experimental Treatment
Group I: Prostatic Artery Embolization (PAE)Experimental Treatment2 Interventions
Participants who receive PAE with Merit Medical Embospheres.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
543 Previous Clinical Trials
135,456 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,158 Patients Enrolled for Prostate Cancer
Nainesh S Parikh, MD, MBAPrincipal InvestigatorMoffitt Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can undergo a procedure to block blood flow to my prostate within 6-12 weeks after my radiation therapy.I am currently on hormone therapy for my cancer.You have a high score on the AUA or IPSS test measuring urinary symptoms.I have low-grade prostate cancer and chose to monitor it rather than treat it immediately.My organ and bone marrow functions are normal.I have severe allergies to contrast dyes used in scans and cannot be pre-medicated for them.I had prostate surgery within the last 2 years.My prostate is larger than 150 grams.My prostate cancer is low risk and I've chosen radiation therapy.My prostate is between 60 and 150 grams in size.My prostate cancer is at an intermediate or high risk level.I currently have a urinary tract infection.I cannot have a specific prostate artery procedure within 1.5 to 3 months after my definitive radiation therapy.I have an active bladder stone or prostate infection.
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.
Are there any vacancies for individuals interested in participating in this research?
"Per the information on clinicaltrials.gov, this medical study is currently recruiting participants. It was initially posted in February of 2022 and most recently updated at the end of August that same year."
Answered by AI
Has Radiation Therapy been officially validated by the FDA?
"With only some data indicating safety, we have assessed radiation therapy as having a rating of 2. Due to being in Phase 2 clinical trials, there is no evidence supporting its efficacy yet."
Answered by AI
What is the aggregate number of people participating in this research?
"Affirmative. The clinical trial is actively enrolling patients, as evidenced by the information posted on clinicialtrials.gov; it was created on February 23rd 2022 and most recently revised August 18th of this year. A total of 26 participants are needed for the experiment to be conducted at a single site."
Answered by AI
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