Clinical trial · Interventional
Phase II Investigation of Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients
Phase II Open Label Investigation of the Safety and Efficacy of Pre-Operative Prostate Artery Embolization (PAE) Before Radical Prostatectomy in Prostate Cancer Patients
NCT02173522CI-TRIAL-00039201terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment difficulty
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prostate artery embolization (PAE) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prostate artery embolization (PAE)
- description
- 10 patients will receive prostate artery embolization (PAE) prior to robot-assisted laparoscopic radical prostatectomy (RALRP).
- interventionNames
- Device: Prostate artery embolization (PAE)
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
Primary outcomes (1)
- measure
- Estimated Blood Loss During Robot-assisted Laparoscopic Radical Prostatectomy (RALRP)
- timeFrame
- RALRP procedure, up to 3 hours
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.