New procedure aims to help men with prostate cancer pee easier
NCT ID NCT04879940
First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times
Summary
This study tests a procedure called prostatic artery embolization (PAE) in 17 men with low-risk prostate cancer who also have trouble urinating. The goal is to see if PAE can reduce urinary symptoms before they start radiation therapy. Participants will have their symptoms and prostate size checked over 12 weeks after the procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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17 people
The number who actually took part.
- Started
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Feb 2022
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. * Ability to receive prostatic artery embolization within 6-12 weeks of definitive radiation therapy. * Ability to understand and the willingness to sign a written informed consent document * Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans * American Urologic Association (AUA) or International Prostate Symptom Score (IPSS) Score ≥ 15 * Normal organ and marrow function as defined in protocol Exclusion Criteria: * Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method. * Receiving androgen deprivation therapy (ADT) * Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk localized PCa (Gleason Grade Groups 4 and 5) * Receiving any investigational agents for the explicit purpose of prostatic size reduction * Inability to receive prostatic artery embolization (PAE) within 6-12 weeks of definitive radiation therapy * Active urinary tract infection (UTI) * History of severe allergic reaction to intravenous contrast media (iodinated and gadolinium- based) or any agents used during the PAE; patient cannot be medicated against allergic reaction prior to PAE. * Active cystolithiasis or prostatitis * Inability to have multi-parametric magnetic resonance imaging (mpMRI) * Prior transurethral resection of the prostate (TURP) within 2 years * Prostate size greater than or equal to150 grams * Vulnerable subjects (e.g., inmates and developmentally delayed adults) who are subjects for whom the study may be unsafe or whose rights may be violated with enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Other studies related to the condition(s) this trial covers.
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