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

Who is this study for? Patients with Prostate Carcinoma, Benign Prostatic Hyperplasia
What treatments are being studied? Merit Medical Embospheres+Radiation Therapy
Status: Recruiting
Location: See location...
Intervention Type: Radiation, Device
Study Type: Interventional
Study Phase: Phase 2
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. 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

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 50
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed prostate adenocarcinoma in the very low or low or favorable intermediate risk risk stratification groups (i.e. Gleason Grade groups 1 and 2) who are eligible for and who select XRT as their cancer management method.

• 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

Locations
United States
Florida
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Christine Darbouze
Christine.Darbouze@moffitt.org
813-745-8919
Time Frame
Start Date: 2022-02-23
Estimated Completion Date: 2026-04
Participants
Target number of participants: 26
Treatments
Experimental: Prostatic Artery Embolization (PAE)
Participants who receive PAE with Merit Medical Embospheres.
Sponsors
Leads: H. Lee Moffitt Cancer Center and Research Institute

This content was sourced from clinicaltrials.gov