Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization (NCT04879940) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
United States17 participantsStarted 2022-02-23
Plain-language summary
This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment. PAE will be administered by Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks following PAE after which they will start definitive radiotherapy. After completion of radiotherapy the patient will be seen at 12 weeks
Who can participate
Age range
50 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase II, which means it's still in relatively early stages of testing — what does that mean for how much is known so far about the safety and effectiveness of prostatic artery embolization for my specific situation?
2The trial is measuring something called the International Prostate Symptom Score — can you explain what that score measures and whether improving it would address the symptoms that matter most to me?
3I see this trial covers both prostate cancer and benign prostatic hyperplasia — given my diagnosis, which condition is this procedure primarily being evaluated for in my case, and does that affect how relevant the trial's findings would be for me?
4Since the trial is listed as 'active, not recruiting,' does that mean enrollment is closed and I can no longer join, and if so, are there similar studies or standard treatment options I should be considering instead?
5Compared to standard treatments for my condition — like surgery, medication, or radiation — what are the potential advantages and risks of prostatic artery embolization that I should weigh before deciding whether this approach makes sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in International Prostate Symptom Score
Timeframe: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE
Trial details
NCT IDNCT04879940
SponsorH. Lee Moffitt Cancer Center and Research Institute