PAE + Radiation for Prostate Cancer

Overseen By Christine Darbouze

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Androgen deprivation, Investigational agents

Disqualifiers: Unfavorable PCa, UTI, Allergic reaction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment approach for prostate cancer patients who also experience urination difficulties due to an enlarged prostate. It aims to determine if Prostatic Artery Embolization (PAE)—a procedure that blocks blood flow to shrink the prostate—can enhance the effectiveness of radiation therapy. This trial is best suited for participants with confirmed low-risk prostate cancer who have chosen radiation therapy and experience significant urinary issues. Participants will undergo PAE and then begin radiation therapy a few weeks later, with follow-ups to monitor progress. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you are receiving androgen deprivation therapy or investigational agents for prostate size reduction.

What prior data suggests that Prostatic Artery Embolization is safe for prostate cancer patients?

Research has shown that Prostatic Artery Embolization (PAE) is generally safe for patients. Studies have found that PAE significantly improves urinary symptoms in over 90% of men, indicating better urinary function after the procedure for most. Another study found that PAE did not negatively affect erectile function, which reassures many patients. Additionally, PAE is considered a safe outpatient procedure, often not requiring an overnight hospital stay. The studies also showed no need for a urethral catheter (a tube to help with urination) and no reports of needing a blood transfusion during the procedure. Overall, these findings suggest that PAE is a safe and promising treatment option. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Prostatic Artery Embolization (PAE) is unique because it offers a minimally invasive option for treating prostate cancer by blocking blood flow to the prostate, which can shrink the tumor. Unlike traditional treatments like surgery or radiation therapy, PAE uses tiny particles called Embospheres to target the blood vessels feeding the prostate directly. This targeted approach potentially reduces side effects and recovery time, making it an exciting option for those looking for less invasive treatment alternatives. Researchers are particularly interested in how PAE might improve patient outcomes with fewer complications compared to more conventional methods.

What evidence suggests that Prostatic Artery Embolization is effective for prostate cancer?

In this trial, participants will receive Prostatic Artery Embolization (PAE) as an experimental treatment. Previous studies have shown that PAE holds promise for treating urinary issues related to prostate conditions. Research indicates that PAE can significantly shrink the prostate in most cases, facilitating other treatments. In the short term, many men reported fewer severe urinary symptoms. Specifically, about 90% of participants experienced symptom improvement. Additionally, at a 3-month follow-up, 83% of patients showed successful treatment results. This suggests PAE might effectively ease urinary problems for those undergoing prostate cancer treatment. ^{1 2 5 6 7}

Who Is on the Research Team?

Nainesh S Parikh, MD, MBA

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

Men with low to intermediate-risk prostate cancer who choose radiation therapy and have a prostate size between 60-150 grams. They must understand the study and consent to participate, have normal organ function, an AUA or IPSS Score of 15 or more, and be able to undergo PAE within 6-12 weeks before radiotherapy.

Inclusion Criteria

I can undergo a procedure to block blood flow to my prostate within 6-12 weeks after my radiation therapy.

You have a high score on the AUA or IPSS test measuring urinary symptoms.

My organ and bone marrow functions are normal.

Exclusion Criteria

Inability to have multi-parametric magnetic resonance imaging (mpMRI)

I am currently on hormone therapy for my cancer.

I have low-grade prostate cancer and chose to monitor it rather than treat it immediately.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prostatic Artery Embolization (PAE)

Participants undergo Prostatic Artery Embolization administered by Interventional Radiology

1 day

1 visit (in-person)

Follow-up after PAE

Participants are monitored at 6 weeks and 12 weeks following PAE

12 weeks

2 visits (in-person)

Radiotherapy

Participants start definitive radiotherapy after follow-up

6 weeks

Follow-up after Radiotherapy

Participants are monitored for safety and effectiveness 12 weeks after radiotherapy

12 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Prostatic Artery Embolization

Trial Overview The trial is testing if Prostatic Artery Embolization (PAE) performed prior to radiation therapy can improve outcomes for patients with prostate cancer. Participants will receive PAE by Interventional Radiology followed by regular check-ups leading up to their definitive radiotherapy.

How Is the Trial Designed?

Group I: Prostatic Artery Embolization (PAE) Experimental Treatment 2 Interventions

Participants who receive PAE with Merit Medical Embospheres.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12464020/

Effectiveness and Safety of Prostatic Artery Embolization for ... The results showed a significant PV reduction (< 60 mL) in 86% of cases, which enabled the application of the local therapy. In addition, other ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2405456925002470

Long-term Outcomes of Prostatic Artery Embolisation At short-term follow-up, PAE reduces severe LUTS by approximately 10 points on the International Prostate Symptom Score [3,4,6]. However, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11775958/

Prostate Artery Embolization in the Setting of Prostate Cancer This study demonstrated that approximately 90% of men had clinical improvement in LUTS, similar to findings reported above from studies that ...

4. cvirendovasc.springeropen.com cvirendovasc.springeropen.com/articles/10.1186/s42155-025-00562-x

Predicting early clinical success of prostate artery ... Clinical outcomes. At the 3-month follow-up, clinical success was achieved in of 44/53 (83%) patients. The remaining 9/53 ...

5. auajournals.org auajournals.org/doi/10.1097/JU.0000000000003976

Prostate Artery Embolization for Benign Prostatic Hyperplasia These trials report a PSA decrease of approximately 20% to 40%, reaching its nadir at 6 months. MRI findings post PAE demonstrate a 20% to 30% ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/10732748251317691

Prostate Artery Embolization in the Setting of Prostate Cancer These studies showed that PAE resulted in >90% of men experiencing significant LUTS improvement (ie, LUTS improvement from the severe category ...

7. jvir.org jvir.org/article/S1051-0443(24)00698-5/fulltext

Prostatic Artery Embolization: Mid- to Long-Term Outcomes ... PAE offered relief from urinary retention and decreased BPO medication use. PAE had a favorable safety profile including no adverse effect on erectile function.