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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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