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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
Must not have
Receiving androgen deprivation therapy (ADT)
Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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My prostate cancer is low risk and I've chosen radiation therapy.
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My prostate is between 60 and 150 grams in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on hormone therapy for my cancer.
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I have low-grade prostate cancer and chose to monitor it rather than treat it immediately.
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I have severe allergies to contrast dyes used in scans and cannot be pre-medicated for them.
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My prostate is larger than 150 grams.
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My prostate cancer is at an intermediate or high risk level.
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I currently have a urinary tract infection.
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I have an active bladder stone or prostate infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in International Prostate Symptom Score
Secondary study objectives
Change in American Urologic Association Score
Prostate Volume Reduction after PAE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
562 Previous Clinical Trials
144,822 Total Patients Enrolled
27 Trials studying Prostate Cancer
4,159 Patients Enrolled for Prostate Cancer
Nainesh S Parikh, MD, MBAPrincipal InvestigatorMoffitt Cancer Center

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04879940 — Phase 2
Prostate Cancer Research Study Groups: Prostatic Artery Embolization (PAE)
Prostate Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04879940 — Phase 2
Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04879940 — Phase 2
~0 spots leftby Dec 2024
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