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

D

Dominik Abt

Status

Completed

Conditions

Prostate Cancer

Treatments

Device: Prostatic Artery Embolization (PAE)

Study type

Interventional

Funder types

Other

Identifiers

NCT02917161
CTU 15/015

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

Male

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Prostatic Artery Embolization (PAE)
Experimental group
Description:
PAE is performed 6weeks before RALP
Treatment:
Device: Prostatic Artery Embolization (PAE)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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