This phase II trial tests whether prostatic artery embolization (PAE) works to improve urinary symptoms when performed prior to radiation therapy in patients with prostate cancer that is restricted to the site of origin, without evidence of spread (localized). Embolization is a procedure in which substances are injected into blood vessels adjacent to a tumor for the purpose of interrupting the blood flow to the cancer cells. Interrupting the blood flow to tumors may reduce the size or slow the growth.
Additional locations may be listed on ClinicalTrials.gov for NCT04879940.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Nainesh Parikh
Phone: 813-745-8425
PRIMARY OBJECTIVE:
I. To assess the clinical efficacy of PAE on lower urinary tract symptoms (LUTS).
SECONDARY OBJECTIVES:
I. To assess prostate volume reduction after PAE.
II. To assess acute genitourinary (GU) toxicity after PAE.
III. To assess oncologic effect of PAE.
CORRELATIVE OBJECTIVES:
I. To assess for clinical or imaging signs of disease progression after PAE before definitive radiotherapy.
II. To assess effects of PAE on treatment planning.
OUTLINE:
Patients undergo PAE using Merit Medical Embospheres. Patients may receive alpha-blockers (tamsulosin hydrochloride [flomax]) and dutasteride (avodart) for up to 6 weeks after PAE. Patients may then undergo external beam radiation therapy (EBRT) or stereotactic body radiation therapy (SBRT) at the discretion of co-investigator.
After completion of study treatment, patients are followed up at 6 and12 weeks and 6 and 12 months after PAE as well as at 12 weeks after radiation therapy.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorNainesh Parikh