NCT04879940Active, not recruitingPhase 2
Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients With Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 5 May 2021
- Start date
- 23 Feb 2022
- Primary completion date
- 16 Jun 2026
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Diseases
- Prostate cancer
- NCT number
- NCT04879940
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 17
- From 23 Feb 2022 to the primary completion date, 16 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving androgen deprivation therapy (ADT)
- 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
- 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.
- Prior transurethral resection of the prostate (TURP) within 2 years
Other illness
- Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method.
- Active urinary tract infection (UTI)
Other
- Patients with unfavorable intermediate (Gleason Grade Group 3) or high risk localized PCa (Gleason Grade Groups 4 and 5)
- Active cystolithiasis or prostatitis
- Inability to have multi-parametric magnetic resonance imaging (mpMRI)
- 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.
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.