Status:
RECRUITING
Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Conditions:
Prostate Carcinoma
Benign Prostatic Hyperplasia
Eligibility:
MALE
50+ years
Phase:
PHASE2
Brief 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 Emboli...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04879940
Start Date
February 23 2022
End Date
April 1 2026
Last Update
October 31 2025
Active Locations (1)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612