TheranosticTrials.org

Clinical Trial · NCT03344211

Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer

Overview

This randomized phase II trial studies how well enzalutamide with or without radium Ra 223 dichloride in treating patients with castration-resistant prostate cancer that has spread to other places in the body. Enzalutamide is an androgen receptor inhibitor that may slow down the growth of prostate cancer by blocking the action of the male hormone testosterone and other male hormones called androgens. Radiation therapy uses high energy alpha particles to kill tumor cells and shrink tumors. Enzalutamide with or without radium Ra 223 dichloride may work better in treating patients with castration-resistant prostate cancer.

Sponsor

University of Southern California

Phase

Phase 2

Contacts

David I Quinn, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03344211

Drug / Compound

dichloride

Isotope(s):
Target(s):
  • Bone Metabolism
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Symptomatic progression (ex: increase in pain despite stable imaging) AND despite ongoing luteinizing hormone-releasing hormone (LHRH) therapy OR testosterone level \< 50
  • Castration resistance will be defined as the development of disease progression, defined as one of the following:
  • Rising PSA x 2 values \>= 2 weeks apart; minimum absolute PSA value 2 ng/mL
  • * Men with metastatic, castration resistant prostate cancer involving the bone, which is symptomatic or asymptomatic
  • Radiographic progression, with at least 1 new site of metastasis

Exclusion

  • Concurrent oral corticosteroid use aside from adrenal replacement, or use of other immunosuppressive agents (ex: infliximab); topical or inhaled steroids will be allowed
  • Prior treatment with ARN-509 or enzalutamide (there is a grace period for men who wish to enroll and who have recently started enzalutamide for the first time but have taken less than 15 days of therapy)
  • * Prior treatment with docetaxel or cabazitaxel for mCRPC
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium- 153, rhenium-186, or rhenium-188, or radium Ra 223 dichloride) for the treatment of bony metastases
  • Concurrent use of androgen deprivation therapy aside from LHRH agonist or antagonist (i.e. bicalutamide, flutamide, nilutamide, abiraterone, ketoconazole, estrogen); there will be a 2 week wash-out period from the last dose of any of these agents until the first dose of enzalutamide on study; patients who have just started enzalutamide for fewer than 5 doses prior to enrollment in the trial are still considered eligible and not subject to wash-out