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

NCT02173522 | Terminated Results DMC

• 1 other identifier: 20131034
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Prostate cancer; Prostate artery embolization; Robot-assisted laparoscopic radical prostatectomy

Outcome Measures

Primary Outcomes (1)

• Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)

  Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.

  RALRP procedure, up to 3 hours

Secondary Outcomes (14)

• Change in Hemoglobin Compared to Baseline

  Baseline, RALRP post operative day

• Change in Hematocrit

  Baseline, RALRP post operative day 1

• Change in Prostate Volume

  Baseline, 6 weeks post PAE

• Number of Patients That Required Blood Transfusion

  RALRP procedure

• RALRP Duration

  RALRP procedure

Study Arms (2)

Prostate artery embolization (PAE)

EXPERIMENTAL

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

Device: Prostate artery embolization (PAE)

Control

NO INTERVENTION

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.

Interventions

Prostate artery embolization (PAE) DEVICE

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

Prostate artery embolization (PAE)

Eligibility Criteria

• Age: 45 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shivank Bhatia: lead
• Merit Medical Systems, Inc.: collaborator
• Society of Interventional Radiology Foundation: collaborator

Study Sites (1)

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Shivank Bhatia
• Organization: University of Miami

sbhatia1@med.miami.edu

305-243-7500

Study Officials

• Shivank Bhatia, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Radiology

Study Record Dates

• First Submitted: May 22, 2014
• First Posted: June 25, 2014
• Study Start: July 1, 2014
• Primary Completion: June 16, 2017
• Study Completion: June 16, 2017
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2019-06

Locations

US (1)