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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02917161
• Other study ID #: CTU 15/015
• Status: Completed
• Phase: N/A
• First received: September 24, 2016
• Last updated: August 8, 2017
• Start date: September 2016
• Est. completion date: August 3, 2017

Study information

• Verified date: August 2017
• Source: Cantonal Hospital of St. Gallen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 3, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Prostatic Artery Embolization (PAE)
PAE is performed 6 weeks before radical prostatectomy

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Lucerne, Department of Urology	Lucerne
Switzerland	Urological Department, Cantonal Hospital of St. Gallen	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Dominik Abt

Country where clinical trial is conducted

Switzerland, 

Outcome

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