Prostatic Artery Embolization Before Radical Prostatectomy in Prostate Cancer: A Proof-of-concept Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 12
- Locations
- 4
- Primary Endpoint
- Tumor response
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 75 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Prostatic Artery Embolization (PAE)
PAE is performed 6weeks before RALP
Intervention: Prostatic Artery Embolization (PAE) (Device)
Outcomes
Primary Outcomes
Tumor response
Time Frame: 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 Outcomes
- 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))
- 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)
Investigators
Dominik Abt
Dr. med.
Cantonal Hospital of St. Gallen