Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Device: Prostatic Artery Embolization (PAE)

• Registration Number: NCT02917161
• Lead Sponsor: Dominik Abt

Brief Summary

MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.

This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

Detailed Description

MRI findings after successful PAE in patients suffering from BPH suggest a complete necrosis of the prostate after this intervention. Thus, PAE might also play a role in the treatment of prostate cancer.

This proof of concept study assess the impact of PAE in patients with proven prostate cancer.

PAE is performed in patients that are planned to undergo robot-assisted laparoscopic prostatectomy for proven localized prostate cancer.

The impact of neo-adjuvantly performed PAE on histological tumor regression, surgical margins as well as on safety parameters are assessed.

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-24
• Study First Submitted QC: 2016-09-26
• Study First Posted: 2016-09-28
• Primary Completion: 2017-06
• Status Verified: 2017-08
• Study Completion: 2017-08-03
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Men 45 - 75 years old undergoing RALP
• Patient has biopsy-proven prostate adenocarcinoma
• Localized disease (tumorstage cT1-cT2), assessed by clinical and MRI findings
• Written informed consent

Exclusion Criteria

• Severe atherosclerosis
• Severe tortuosity or ectasia in the aortic bifurcation or internal iliac arteries
• Tumor stage > cT2 assessed by clinical and MRI findings
• Allergy to intravenous contrast media
• Contraindication for MRI imaging
• Renal failure (GFR<60ml/min)
• History of pelvic irradiation or radical pelvic surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prostatic Artery Embolization (PAE)	Prostatic Artery Embolization (PAE)	PAE is performed 6weeks before RALP

Primary Outcome Measures

Name	Time	Method
Tumor response	6 weeks after PAE (at the time of RALP)	Histological assessment of the excised prostate to determine whether pathological complete response was achieved, defined as complete absence of histologically identifiable cancer cells in the excised prostate.

Secondary Outcome Measures

Name	Time	Method
Histological Tumor Regression Grade	6 weeks after PAE (at the time of RALP)
Surgical margins assessment (R0 /R1)	6 weeks after PAE (at the time of RALP)	- Success of radical prostatectomy defined as the complete resection of cancerous prostate gland tissue and completely negative surgical margins.
Assessment of Adverse Events of PAE according to CTCAE V4.03	At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of PAE according to Clavien-Dindo classification	At the time of PAE and 6 weeks afterwards
Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03	At the time of RALP, 6 weeks and 12 weeks later
Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification	At the time of RALP, 6 weeks and 12 weeks later
Change of prostate volume in MRI after PAE	Before and 6 weeks after PAE
Change of tumor detection rate in MRI after PAE	Before and 6 weeks after PAE
Change of tumor size in MRI after PAE	Before and 6 weeks after PAE
Change of PIRADS classification in MRI after PAE	Before and 6 weeks after PAE

Trial Locations

Locations (2)

Cantonal Hospital Lucerne, Department of Urology; 🇨🇭 Lucerne, Switzerland

Urological Department, Cantonal Hospital of St. Gallen; 🇨🇭 St. Gallen, Switzerland