PAE + Radiation for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byNainesh S Parikh, MD, MBA

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Prior Safety Data

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

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.

See 3 more

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.

See 9 more

Treatment Details

Interventions

Prostatic Artery Embolization (Procedure)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Prostatic Artery Embolization (PAE)Experimental Treatment2 Interventions

Participants who receive PAE with Merit Medical Embospheres.