Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
Conditions
Prostate Carcinoma, Benign Prostatic HyperplasiaSummary
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
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Scott Hagen
- 813-745-0683
- [email protected]
Principal Investigator
- Nainesh S Parikh, MD, MBA
Eligibility Criteria
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.
Study Plan
Prostatic Artery Embolization (PAE)
EXPERIMENTAL
Participants who receive PAE with Merit Medical Embospheres.
DEVICE:
Merit Medical EmbospheresDescription:
Prostatic Artery Embolization will performed as an outpatient procedure in Interventional Radiology. Bilateral selective pelvic angiograms will be performed to localize the prostatic arteries. Cone-beam or 3D computed tomography (CT) will be performed prior to embolization, if technically feasible and necessary. Embolization will be performed using Merit Medical Embospheres.RADIATION:
Radiation TherapyDescription:
Patients will undergo standard of care definitive radiation therapy.
Outcome Measures
Primary Outcome Measures
Change in International Prostate Symptom Score
Secondary Outcome Measures
Prostate Volume Reduction after PAE
Change in American Urologic Association Score
Timeline
Last Updated
January 9, 2025Start Date
May 10, 2021Today
May 11, 2025Completion Date ( Estimated )
February 1, 2025
Sponsors of this trial
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute