Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization

H. Lee Moffitt Cancer Center and Research Institute

Status and phase

Enrolling

Phase 2

Conditions

Prostate Carcinoma

Benign Prostatic Hyperplasia

Treatments

Radiation: Radiation Therapy

Device: Merit Medical Embospheres

Study type

Interventional

Funder types

Other

Identifiers

NCT04879940

MCC-20832

Details and patient eligibility

About

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

Enrollment

26 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.