Clinical trial NCT02917161: Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
Official title: Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate
Prostatic Neoplams
Therapeutic Embolization
Prostatectomy
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 12
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor response
timeFrame: 6 weeks after PAE (at the time of RALP)
Secondary outcomes:
measure: Histological Tumor Regression Grade
timeFrame: 6 weeks after PAE (at the time of RALP)
measure: Surgical margins assessment (R0 /R1)
timeFrame: 6 weeks after PAE (at the time of RALP)
measure: Assessment of Adverse Events of PAE according to CTCAE V4.03
timeFrame: At the time of PAE and 6 weeks afterwards
measure: Assessment of Adverse Events of PAE according to Clavien-Dindo classification
timeFrame: At the time of PAE and 6 weeks afterwards
measure: Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03
timeFrame: At the time of RALP, 6 weeks and 12 weeks later
measure: Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification
timeFrame: At the time of RALP, 6 weeks and 12 weeks later
measure: Change of prostate volume in MRI after PAE
timeFrame: Before and 6 weeks after PAE
measure: Change of tumor detection rate in MRI after PAE
timeFrame: Before and 6 weeks after PAE
measure: Change of tumor size in MRI after PAE
timeFrame: Before and 6 weeks after PAE
measure: Change of PIRADS classification in MRI after PAE
timeFrame: Before and 6 weeks after PAE
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Cantonal Hospital Lucerne, Department of Urology
city: St. Gallen
country: Switzerland
facility: Urological Department, Cantonal Hospital of St. Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen
name: Dominik Abt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cantonal Hospital Luzerne
name: Livio Mordasini, MD
role: PRINCIPAL_INVESTIGATOR
References: