PAE + Radiation for Prostate Cancer

Overseen By Scott Hagen

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

Trial Summary

What is the purpose of this trial?

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

Research Team

Nainesh S Parikh, MD, MBA

Principal Investigator

Moffitt Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+