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

Not Applicable

Terminated

Conditions: Prostate Cancer

Interventions: Device: Prostate artery embolization (PAE)

Registration Number: NCT02173522

Lead Sponsor: Shivank Bhatia

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 4

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)	RALRP procedure, up to 3 hours	Blood loss during the robotic prostatectomy will be estimated by the surgeon performing the procedure.

Secondary Outcome Measures

Name	Time	Method
Change in Hematocrit	Baseline, 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.
Length of Hospital Stay After RALRP	48 hours post procedure
RALRP Duration	RALRP procedure
Change in Hemoglobin Compared to Baseline	Baseline, RALRP post operative day	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 Prostate Volume	Baseline, 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.
Return to Continence	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.
Change From Baseline in Erectile Function at One Year Post RALRP	Baseline,1 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
Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer	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	1 year post RALRP	Biochemical recurrence of prostate cancer will be determined by PSA levels 1 year following the RALRP procedure.
Number of Patients That Required Blood Transfusion	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.
Histologic Changes in the Prostate After PAE	Between baseline prostate biopsy and RALRP	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.
RALRP-related Adverse Events	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	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.
Change in PSA Following PAE	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.