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

Primary Purpose

Prostate Carcinoma, Benign Prostatic Hyperplasia

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Merit Medical Embospheres

Radiation Therapy

About this trial

This is an interventional supportive care trial for Prostate Carcinoma

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

Moffitt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prostatic Artery Embolization (PAE)

Arm Description

Participants who receive PAE with Merit Medical Embospheres.

Outcomes

Primary Outcome Measures

Change in International Prostate Symptom Score

Participants will take quality of life questionnaires including the International Prostate Symptom Score (IPSS)questionnaire to determine changes in prostate symptoms. Questionnaire will be taken at screening, Day 0- day of prostatic artery embolization (PAE), and at 6 weeks and 12 weeks after PAE. The IPSS asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always".

Secondary Outcome Measures

Prostate Volume Reduction after PAE

Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume.

Change in American Urologic Association Score

Participants will take quality of life questionnaires including the American Urologic Association (AUA) test to assess genitourinary toxicity after PAE and radiation therapy. The AUA questionnaire asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always".

Full Information

NCT ID

NCT04879940

First Posted

May 5, 2021

Last Updated

October 17, 2023

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04879940

Brief Title

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

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 23, 2022 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Carcinoma, Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prostatic Artery Embolization (PAE)

Arm Type

Experimental

Arm Description

Participants who receive PAE with Merit Medical Embospheres.

Intervention Type

Device

Intervention Name(s)

Merit Medical Embospheres

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Radiation Therapy

Intervention Description

Patients will undergo standard of care definitive radiation therapy.

Primary Outcome Measure Information:

Title

Change in International Prostate Symptom Score

Description

Time Frame

At screening, Day of PAE, and 6 weeks & 12 weeks after PAE

Secondary Outcome Measure Information:

Title

Prostate Volume Reduction after PAE

Description

Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume.

Time Frame

At 12 weeks

Title

Change in American Urologic Association Score

Description

Time Frame

At 18 weeks

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cassie Angelo

Phone

813-745-4584

Cassie.Angelo@moffitt.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nainesh S Parikh, MD, MBA

Organizational Affiliation

Moffitt Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cassie Angelo

Phone

813-745-4584

Cassie.Angelo@moffitt.org

First Name & Middle Initial & Last Name & Degree

Nainesh S Parikh, MD, MBA

First Name & Middle Initial & Last Name & Degree

Julio Pow Sang, MD

First Name & Middle Initial & Last Name & Degree

Michael Poch, MD

First Name & Middle Initial & Last Name & Degree

Brandon Manley, MD

First Name & Middle Initial & Last Name & Degree

Kosj Yamoah, MD, PhD

First Name & Middle Initial & Last Name & Degree

Javier F Torres-Roca, MD

First Name & Middle Initial & Last Name & Degree

Peter A Johnstone, MD

First Name & Middle Initial & Last Name & Degree

Daniel Grass, MD

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.moffitt.org/clinical-trials-research/clinical-trials/

Description

Moffitt Cancer Center Clinical Trials website

Learn more about this trial

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

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