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

Stopped early · Not applicable

Conditions studied: Prostate Cancer

In brief

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).

Key facts

Study ID

NCT02173522

Run by

Shivank Bhatia

People needed

4

Starts

2014-07-01

Expected to finish

2017-06-16

Last updated by the study team

2019-06-25

Who can join

Age: 45 and older, up to 79. Sex: male. Healthy volunteers: not accepted.

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
• 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

Where it is running

• Sylvester Comprehensive Cancer Center — Miami, Florida, United States

Full record on ClinicalTrials.gov

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