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NCT Number: NCT02917161

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

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

45 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cantonal Hospital Lucerne, Department of Urology, Lucerne, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostatic Artery Embolization (PAE)

Device

PAE is performed 6 weeks before radical prostatectomy

Primary outcomes

  1. 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

  1. Histological Tumor Regression Grade

    Time frame: 6 weeks after PAE (at the time of RALP)

  2. Surgical margins assessment (R0 /R1)

    Time frame: 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.

  3. Assessment of Adverse Events of PAE according to CTCAE V4.03

    Time frame: At the time of PAE and 6 weeks afterwards

  4. Assessment of Adverse Events of PAE according to Clavien-Dindo classification

    Time frame: At the time of PAE and 6 weeks afterwards

  5. Assessment of Adverse Events of RALP after PAE according to CTCAE V4.03

    Time frame: At the time of RALP, 6 weeks and 12 weeks later

  6. Assessment of Adverse Events of RALP after PAE according to Clavien-Dindo classification

    Time frame: At the time of RALP, 6 weeks and 12 weeks later

  7. Change of prostate volume in MRI after PAE

    Time frame: Before and 6 weeks after PAE

  8. Change of tumor detection rate in MRI after PAE

    Time frame: Before and 6 weeks after PAE

  9. Change of tumor size in MRI after PAE

    Time frame: Before and 6 weeks after PAE

  10. Change of PIRADS classification in MRI after PAE

    Time frame: Before and 6 weeks after PAE

Sponsors and collaborators

Lead sponsor

Dominik Abt

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 28, 2016
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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