RECRUITING

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

Conditions

Prostate Carcinoma Benign Prostatic Hyperplasia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2022-02-23

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04879940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Scott Hagen

CONTACT

813-745-0683

scott.hagen@moffitt.org

Principal Investigator

Nainesh S Parikh, MD, MBA

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Nainesh S Parikh, MD, MBA, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-23

Study Completion Date2024-12

Study Record Updates

Study Start Date2022-02-23

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Prostate Carcinoma
Benign Prostatic Hyperplasia