Description:
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. PAE will be administered by
Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks
following PAE after which they will start definitive radiotherapy. After completion of
radiotherapy the patient will be seen at 12 weeks
Title
- Brief Title: Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization
- Official Title: 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
Clinical Trial IDs
- ORG STUDY ID:
MCC-20832
- NCT ID:
NCT04879940
Conditions
- Prostate Carcinoma
- Benign Prostatic Hyperplasia
Purpose
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. PAE will be administered by
Interventional Radiology. Patients will be seen for follow-up at 6 weeks and 12 weeks
following PAE after which they will start definitive radiotherapy. After completion of
radiotherapy the patient will be seen at 12 weeks
Trial Arms
Name | Type | Description | Interventions |
---|
Prostatic Artery Embolization (PAE) | Experimental | Participants who receive PAE with Merit Medical Embospheres. | |
Eligibility 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
Exclusion Criteria:
- Receiving androgen deprivation therapy (ADT)
- Patients with intermediate 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 150 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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 50 Years |
Eligible Gender: | Male |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Change in International Prostate Symptom Score |
Time Frame: | At screening, Day of PAE, and 6 weeks & 12 weeks after PAE |
Safety Issue: | |
Description: | Participants will take quality of life questionnaires including the International Prostate Symptom Score (IPSS)questionnaire to determine changes in prostate symptoms. Questionnaire will be taken at screening, Day 0- day of prostatic artery embolization (PAE), and at 6 weeks and 12 weeks after PAE. The IPSS asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always". |
Secondary Outcome Measures
Measure: | Prostate Volume Reduction after PAE |
Time Frame: | At 12 weeks |
Safety Issue: | |
Description: | Prostate volume will be determined by MRI prior to PAE and at 12 weeks post PAE to determine changes in volume. |
Measure: | Change in American Urologic Association Score |
Time Frame: | At 18 weeks |
Safety Issue: | |
Description: | Participants will take quality of life questionnaires including the American Urologic Association (AUA) test to assess genitourinary toxicity after PAE and radiation therapy. The AUA questionnaire asks the patient to rate urinary symptoms on a scale of 0-5, 0 indicating indicating the participant has not had a symptom at all, and 5 indicating the symptom "almost always". |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Not yet recruiting |
Lead Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
Last Updated
August 25, 2021