Phase II Study to Evaluate the Safety and Efficacy of Prostatic Artery Embolization

Launched by H. LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE · May 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Prostatic Artery Embolization (PAE) to see if it can help men with prostate cancer and urinary problems before they start radiation therapy. In this study, men who have been diagnosed with certain types of prostate cancer and who have a prostate size between 60 and 150 grams may be eligible. They need to have specific symptoms related to urination and be able to undergo PAE before starting their radiation treatment.

Participants in the trial will have the PAE procedure done by a specialized doctor and will have follow-up appointments to check on their health six and twelve weeks after the procedure. After the follow-ups, they will begin their radiation therapy. It's important to note that this study is looking for men with certain risk categories for prostate cancer and who are not receiving other specific treatments. If you think you might qualify and are interested in participating, it's best to discuss this with your healthcare provider for more personalized information.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • Patients with Gleason Grade Group 1 or 2 PCa who select active surveillance as their cancer management method.
• • Receiving androgen deprivation therapy (ADT)
• • Patients with unfavorable intermediate (Gleason Grade Group 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.