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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Open Label Investigation of the Safety and Efficacy of Pre-Operative Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: Prostate artery embolization (PAE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate artery embolization (PAE)<br>10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP). | Device: Prostate artery embolization (PAE)<br>* Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hemoglobin Compared to Baseline | 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. | Baseline, RALRP post operative day | 
| Change in Hematocrit | 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. | Baseline, RALRP post operative day 1 | 
| Change in Prostate Volume | 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. | Baseline, 6 weeks post PAE | 
| Number of Patients That Required Blood Transfusion | 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 procedure | 
| RALRP Duration |  | RALRP procedure | 
| Length of Hospital Stay After RALRP |  | 48 hours post procedure | 
| Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer | Histopathology examination post RALRP will be used to determine if the prostatectomy procedure succeeded in removing the entire cancer. | RALRP procedure | 
| Biochemical Recurrence of Prostate Cancer | Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure. | 1 year post RALRP | 
| Return to Continence | 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. | An expected average of 1 week post RALRP | 
| RALRP-related Adverse Events | 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. | Through 1 year post RALRP | 
| PAE-related Adverse Events | 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. | Through 1 year post RALRP | 
| Change From Baseline in Erectile Function at One Year Post RALRP | The International Index of Erectile Function (IIEF) questionnaire is a multi-dimensional self-administered test found to be used in the clinical assessment of erectile dysfunction. It examines the 4 main domains of male sexual function. A higher score would indicated less dysfunction. The scores can range 6 to 75 | Baseline,1 year post RALRP | 
| Change in PSA Following PAE | Patients who undergo PAE will have blood tests to determine the change in their PSA levels between baseline and 6 weeks post PAE. | 6 weeks post PAE | 
| Histologic Changes in the Prostate After PAE | The Gleason Score prostate Cancer Grading and Prognostic scoring system will be used to determine the histologic changes in the prostate tumor. Since prostate tumors are often made up of cancerous cells that have different grades, two grades are assigned to each patient. A primary grade is given to describe the cells that make up the largest area of the tumor and a secondary grade is given to describe the cells of the next largest area. The sums of the scores will be evaluated. The Gleason Score sum will range from 1 - 10, with the higher score indicating a more advanced neoplasm. | Between baseline prostate biopsy and RALRP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Prostate artery embolization, Robot-assisted laparoscopic radical prostatectomy