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Clinical Trial 20832

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT04879940

Phase: Phase II
Prinicipal Investigator: Parikh, Nainesh

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Overview

Study Title

A Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization in Patients with Localized Prostate Carcinoma and Obstructive Lower Urinary Tract Symptoms

Summary

This is a Phase II prospective clinical trial in which patients with prostate carcinoma and obstructive lower urinary tract symptoms electing for radiation therapy will undergo Prostatic Artery Embolization (PAE) prior to treatment.

Objective

Primary Objective: To assess the clinical efficacy of PAE on LUTS Secondary Objectives: (i) To assess prostate volume reduction after PAE. (ii) To assess acute GU toxicity after PAE Correlative Objectives: (i) To assess for clinical or imaging signs of disease progression after PAE before definitive radiotherapy (ii) To assess effects of PAE on treatment planning

Treatments

Therapies

Transarterial Chemoembolization (TACE)

Medications

Inclusion Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low risk risk stratification groups (i.e. Grade group 1 or Gleason score ≤ 6) and eligible for radiation therapy.
  • Ability to receive prostatic artery embolization within 6-12 weeks of definitive radiation therapy.
  • Ability to understand and the willingness to sign a written informed consent document
  • Prostate larger than 60 grams but less than 150 grams, as assessed by imaging scans
  • American Urologic Association (AUA) or International Prostate Symptom Score (IPSS) Score ≥ 15
  • Normal organ and marrow function as defined in protocol
  • Additional criteria may apply

  • Exclusion Criteria

    Exclusion Criteria:

  • Receiving androgen deprivation therapy (ADT)
  • Patients with intermediate (Gleason Grade Groups 2 and 3) or high risk localized PCa (Gleason Grade Groups 4 and 5)
  • Receiving any investigational agents for the explicit purpose of prostatic size reduction
  • Inability to receive prostatic artery embolization (PAE) within 6-12 weeks of definitive radiation therapy
  • Active urinary tract infection (UTI)
  • History of severe allergic reaction to intravenous contrast media (iodinated and gadolinium- based) or any agents used during the PAE; patient cannot be medicated against allergic reaction prior to PAE.
  • Active cystolithiasis or prostatitis
  • Inability to have multi-parametric magnetic resonance imaging (mpMRI)
  • Prior transurethral resection of the prostate (TURP) within 2 years
  • Prostate size greater than or equal to150 grams
  • Vulnerable subjects (e.g., inmates and developmentally delayed adults) who are subjects for whom the study may be unsafe or whose rights may be violated with enrollment
  • Other criteria may apply

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