Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

NCT ID: NCT02173522

Last Updated: 2019-06-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-06-16

Brief Summary

The purpose of this study is to determine whether pre-operative prostate artery embolization (PAE) reduces intra-operative blood loss and improves surgical outcomes among prostate cancer patients undergoing robot-assisted laparoscopic radical prostatectomy (RALRP).

Detailed Description

Duration of study:

This study will enroll 20 patients, with a target enrollment period of 18 months. Patients who undergo prostate artery embolization (PAE) will have follow-up visits 2 weeks and 6 weeks after PAE. All patients in the study will have post RALRP follow-up visits at 2 weeks, 3 months, 6 months, 9 months, and 12 months after surgery. All patients will continue to be followed according to the usual standard of care following the completion of the study.

Study design:

The first 10 patients who meet all study eligibility criteria and provide consent for participation in the study will receive PAE prior to RALRP. Control patients will be matched 1:1 to PAE patients, according to risk score, and will receive RALRP without PAE. Control patients will be selected after all PAE patients have been enrolled, and need not meet all study eligibility criteria.

The following assessments and evaluations are required for participation in this study:

Physical exams, blood & urine tests, magnetic resonance imaging (MRI), digital rectal exams (DREs), transrectal ultrasound (TRUS), Expanded Prostate Cancer Index Composite (EPIC) questionnaires, International Index of Erectile Function (IIEF) questionnaires, robot-assisted laparoscopic radical prostatectomy (RALRP), and pad weight tests. All patients enrolled in the PAE arm of the study will undergo embolization of the blood vessels that feed the prostate.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prostate artery embolization (PAE)

10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).

Group Type: EXPERIMENTAL

Prostate artery embolization (PAE)

Intervention Type: DEVICE

Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.

Control

10 patients, matched to PAE patients by risk score, will receive RALRP without PAE. RALRP without PAE is the current standard of care treatment for prostate cancer at the Sylvester Comprehensive Cancer Center.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prostate artery embolization (PAE)

Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patient is 45-79 years old
• Patient has signed informed consent
• Patient has biopsy-proven prostate adenocarcinoma with localized disease
• Patient is a candidate for robot-assisted laparoscopic radical prostatectomy (RALRP)
• Patient has a prostate size >40 grams

Exclusion Criteria

• Active urinary tract infection
• History of life threatening allergy to iodinated contrast agents
• Any known condition that limits catheter-based intervention or is a contraindication to embolization (eg shunt or adverse arterial anatomy)
• Patient is unable to undergo MRI imaging
• Cardiac condition including congestive heart failure or uncontrolled arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease, or known immunosuppression which required hospitalization within the previous 6 months
• Baseline serum creatinine level > 1.8 mg/dL
• Baseline hemoglobin < 8.0 g/dL
• Active cystolithiasis or prostatitis
• History of pelvic irradiation or radical pelvic surgery
• Known major iliac arterial occlusive disease
• Confirmed or suspected bladder cancer
• Urethral strictures, bladder neck contracture, or other bladder or urethral pathology that could limit catheterization
• Previous rectal surgery (other than hemorrhoidectomy) or history of rectal disease if the therapy or patient evaluation may potentially cause injury to sites of previous rectal surgery, e.g. if a transrectal probe is used
• Previous pelvic irradiation or radical pelvic surgery
• Previous prostate surgery, balloon dilatation, stent implantation, laser prostatectomy, hyperthermia, or any other invasive treatment to the prostate
• Prior transurethral resection of the prostate or other invasive therapies
• Coagulation disturbances not normalized by medical treatment
• Acute urinary retention
• Hypersensitivity to gelatin products
• Any contraindication to embolization, including intolerance to vessel occlusion procedures, vascular anatomy/blood flow that precludes catheter placement or embolic agent injection, presence/likely onset of vasospasm, presence/likely onset of hemorrhage, severe atheromatous disease, feeding arteries smaller than distal branches, arteriovenous shunt, and collateral vessel pathways endangering normal territories during embolization or pelvic inflammatory disease

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Merit Medical Systems, Inc.

INDUSTRY

Sponsor Role: collaborator

Society of Interventional Radiology Foundation

OTHER

Sponsor Role: collaborator

Shivank Bhatia

OTHER

Sponsor Role: lead

Responsible Party

Shivank Bhatia

Assistant Professor of Clinical Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shivank Bhatia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20131034

Identifier Type: -

Identifier Source: org_study_id