Clinical trial NCT04879940: Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Prostate Carcinoma
Benign Prostatic Hyperplasia
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 26
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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


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.

Primary outcomes:
measure: Change in International Prostate Symptom Score
timeFrame: At screening, Day of PAE, and 6 weeks & 12 weeks after PAE
Secondary outcomes:
measure: Prostate Volume Reduction after PAE
timeFrame: At 12 weeks
measure: Change in American Urologic Association Score
timeFrame: At 18 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Nainesh S Parikh, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: