Evaluating Prostatic Artery Embolization for Prostate Cancer Treatment
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
This study is testing if a procedure called Prostatic Artery Embolization can help men with prostate cancer feel better and have fewer urinary problems before they start radiation therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 26 (estimated) |
| Ages | 50 Years and up |
| Sex | Male |
| Sponsor | H. Lee Moffitt Cancer Center and Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tampa, Florida) |
| Trial ID | NCT04879940 on ClinicalTrials.gov |
What this trial studies
This Phase II clinical trial investigates the safety and efficacy of Prostatic Artery Embolization (PAE) in patients with prostate carcinoma who are experiencing obstructive lower urinary tract symptoms and are planning to undergo radiation therapy. Participants will receive PAE prior to starting definitive radiotherapy, with follow-up assessments at 6 and 12 weeks post-embolization. The study aims to determine if PAE can improve patient outcomes and alleviate symptoms before radiation treatment.
Who should consider this trial
Good fit: Ideal candidates include men with histologically confirmed prostate adenocarcinoma in low-risk categories who are eligible for radiation therapy and have significant urinary symptoms.
Not a fit: Patients opting for active surveillance or those with high-risk prostate cancer may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could enhance the quality of life for patients by reducing urinary symptoms and potentially improving the effectiveness of subsequent radiation therapy.
How similar studies have performed: While the use of PAE in this context is relatively novel, similar studies have shown promising results in improving urinary symptoms in patients with benign prostatic hyperplasia.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Tampa, Florida
- Moffitt Cancer Center — Tampa, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Nainesh S Parikh, MD, MBA — Moffitt Cancer Center
- Study coordinator: Scott Hagen
- Email: scott.hagen@moffitt.org
- Phone: 813-745-0683
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.