Clinical trial NCT02173522: Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate cancer
Prostate artery embolization
Robot-assisted laparoscopic radical prostatectomy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Merit Medical Systems, Inc.
name: Society of Interventional Radiology Foundation
First posted: 2014-06-25
Enrollment: 4
Sex: MALE
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)
timeFrame: RALRP procedure, up to 3 hours
Secondary outcomes:
measure: Change in Hemoglobin Compared to Baseline
timeFrame: Baseline, RALRP post operative day
measure: Change in Hematocrit
timeFrame: Baseline, RALRP post operative day 1
measure: Change in Prostate Volume
timeFrame: Baseline, 6 weeks post PAE
measure: Number of Patients That Required Blood Transfusion
timeFrame: RALRP procedure
measure: RALRP Duration
timeFrame: RALRP procedure
measure: Length of Hospital Stay After RALRP
timeFrame: 48 hours post procedure
measure: Number of Participants for Whom Prostatectomy Procedure Did Not Succeed in Removing the Entire Cancer
timeFrame: RALRP procedure
measure: Biochemical Recurrence of Prostate Cancer
timeFrame: 1 year post RALRP
measure: Return to Continence
timeFrame: An expected average of 1 week post RALRP
measure: RALRP-related Adverse Events
timeFrame: Through 1 year post RALRP
measure: PAE-related Adverse Events
timeFrame: Through 1 year post RALRP
measure: Change From Baseline in Erectile Function at One Year Post RALRP
timeFrame: Baseline,1 year post RALRP
measure: Change in PSA Following PAE
timeFrame: 6 weeks post PAE
measure: Histologic Changes in the Prostate After PAE
timeFrame: Between baseline prostate biopsy and RALRP
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
Study officials:
affiliation: University of Miami
name: Shivank Bhatia, MD
role: PRINCIPAL_INVESTIGATOR
References: