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

This study has been completed.
Sponsor:
Collaborators:
Merit Medical Systems, Inc.
Society of Interventional Radiology Foundation
Information provided by (Responsible Party):
Shivank Bhatia, University of Miami
ClinicalTrials.gov Identifier:
NCT02173522
First received: May 22, 2014
Last updated: June 19, 2017
Last verified: June 2017
  Purpose
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).

Condition Intervention
Prostate Cancer Device: Prostate artery embolization (PAE)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Open Label Investigation of the Safety and Efficacy of Pre-Operative Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

Resource links provided by NLM:


Further study details as provided by Shivank Bhatia, University of Miami:

Primary Outcome Measures:
  • Estimated blood loss during robot-assisted laparoscopic radical prostatectomy (RALRP) [ Time Frame: RALRP procedure ]
    Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.


Secondary Outcome Measures:
  • Change in hemoglobin compared to baseline [ Time Frame: RALRP post operative day 1 ]
    Patients will undergo a blood test to assess their hemoglobin level prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hemoglobin level following surgery.

  • Change in hematocrit [ Time Frame: RALRP post operative day 1 ]
    Patients will undergo a blood test to assess their hematocrit prior to surgery on the day of RALRP, and again on post operative day 1 to determine the change in the hematocrit following surgery.

  • Change in prostate volume [ Time Frame: 6 weeks post PAE ]
    Patients who receive PAE will undergo MRIs before PAE and 6 weeks after PAE to assess any change in prostate volume following the embolization procedure.

  • Blood transfusion requirements [ Time Frame: RALRP procedure ]
    Requirement for blood transfusion during the prostatectomy procedure will be assessed in all patients. The surgeon performing the prostatectomy will determine whether or not patients require blood transfusions.

  • RALRP duration [ Time Frame: RALRP procedure ]
  • Length of hospital stay after RALRP [ Time Frame: An expected average of 24-48 hours ]
  • Presence or absence of complete surgical margin [ Time Frame: RALRP procedure ]
    Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer.

  • Biochemical recurrence of prostate cancer [ Time Frame: 1 year post RALRP ]
    Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.

  • Return to continence [ Time Frame: An expected average of 1 week post RALRP ]
    Return to continence following the RALRP procedure will be determined by the pad weight test, conducted at each follow-up visit until the patient is continent.

  • RALRP-related adverse events [ Time Frame: Through 1 year post RALRP ]
    Any adverse event occurring between the date of RALRP and 1 year of follow-up that the investigators determine to be related to the RALRP procedure will be assessed.

  • PAE-related adverse events [ Time Frame: Through 1 year post RALRP ]
    Any adverse event occurring between the date of PAE and 1 year of follow-up that the investigators determine to be related to the PAE procedure will be assessed.

  • Erectile function compared to baseline [ Time Frame: 1 year post RALRP ]
    The International Index of Erectile Function will be used to assess changes in erectile function through 1 year of follow-up post RALRP.

  • Change in PSA following PAE [ Time Frame: 6 weeks post PAE ]
    Patients who undergo PAE will have blood tests to determine the change in their PSA levels between baseline and 6 weeks post PAE.

  • Histologic changes in the prostate after PAE [ Time Frame: Between baseline prostate biopsy and RALRP ]
    Among patients who undergo PAE, histology examination following RALRP will be compared to the histology of the pre-PAE prostate biopsy.


Enrollment: 4
Study Start Date: July 2014
Study Completion Date: June 16, 2017
Primary Completion Date: June 16, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prostate artery embolization (PAE)
10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).
Device: Prostate artery embolization (PAE)
Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.
No Intervention: 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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02173522

Locations
United States, Florida
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
Shivank Bhatia
Merit Medical Systems, Inc.
Society of Interventional Radiology Foundation
Investigators
Principal Investigator: Shivank Bhatia, MD University of Miami
  More Information

Responsible Party: Shivank Bhatia, Assistant Professor of Clinical Radiology, University of Miami
ClinicalTrials.gov Identifier: NCT02173522     History of Changes
Other Study ID Numbers: 20131034, G130237
Study First Received: May 22, 2014
Last Updated: June 19, 2017

Keywords provided by Shivank Bhatia, University of Miami:
Prostate cancer
Prostate artery embolization
Robot-assisted laparoscopic radical prostatectomy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 21, 2017