Last updated on September 2017

Androgen Deprivation Therapy +/- Radium-223 Dichloride in Metastatic Prostate Cancer With Bone Metastases


Brief description of study

Newly diagnosed metastatic prostate cancer subjects with bone metastases will be accrued to this stratified randomized 2-arm Phase II trial. Subjects will be randomized 1:2 to ADT or ADT with Radium-223 dichloride respectively.

Detailed Study Description

OUTLINE: This is a multi-center, randomized trial. STRATIFICATION FACTORS: Subjects will be stratified based on serum total alkaline phosphatase at baseline and extent of disease (described below). Randomization will occur within stratification group. - Extent of Disease: <6 skeletal metastases with no visceral metastases versus ≥6 skeletal metastases or visceral metastases. - Serum total alkaline phosphatase at baseline: normal vs abnormal. Abnormal alkaline phosphatase is defined as > 130 IU/L. Early Induction or Late Induction status will not be a stratification criterion. TREATMENT SCHEDULE: CONTROL ARM A All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist (degarelix) or bilateral orchiectomy, with dosage determined by the treating physician. Route of administration and cycle days will be administered as per package insert. Androgen deprivation therapy with LHRH agonist or LHRH antagonist will be given continuously. All subjects will receive bicalutamide, 50 mg Oral (PO) Daily TREATMENT SCHEDULE: EXPERIMENTAL ARM B All subjects will receive androgen deprivation therapy with a LHRH agonist (any LHRH agonist such as leuprolide acetate or goserelin acetate is acceptable) or a LHRH antagonist (degarelix) or bilateral orchiectomy, with dosage determined by the treating physician. Route of administration and cycle days will be administered as per package insert. Androgen deprivation therapy with LHRH agonist or LHRH antagonist will be given continuously. All subjects will receive bicalutamide, 50 mg oral (PO) daily All subjects will receive Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight, intravenous (IV bolus) every 28 days for 6 injections The following laboratory values must be obtained within 28 days prior to registration for protocol therapy: Hematopoietic: - Hemoglobin (Hgb) ≥ 8.0 g/dL (80 g/L) without packed RBC transfusion - Platelets ≥ 100 K/mm3 - Absolute neutrophil count (ANC) ≥ 1.5 K/mm3 Hepatic: - Total Bilirubin ≤ 2 x institutional upper limit of normal (ULN) except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL - Aspartate aminotransferase (AST, SGOT) ≤ 2.5 x institutional ULN (≤ 5 x institutional ULN in the presence of liver metastases). - Alanine aminotransferase (ALT, SGPT) ≤ 2.5 x institutional ULN (≤ 5 × institutional ULN in the presence of liver metastases). Renal: - Estimated Creatinine Clearance by Cockcroft-Gault formula ≥ 30 mL/min

Clinical Study Identifier: NCT02582749

.

Contact Investigators or Research Sites near you

Start Over

Please choose location

View all locations

Jue Wang, MD

University of Arizona Cancer Center at Dignity Health St. Joseph's
Phoenix, AZ United States
  Connect »

Gary MacVicar, MD

Illinois CancerCare, P. C.
Peoria, IL United States
  Connect »

Costantine Albany, MD

Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, IN United States
  Connect »

Andrew Greenspan, MD

IU Health Central Indiana Cancer Centers
Indianapolis, IN United States
  Connect »

Yousef Zakharia, MD

University of Iowa Hopital and Clinics
Iowa City, IA United States
  Connect »

Jason Hearn, MD

University of Michigan Health System
Ann Arbor, MI United States
  Connect »

Clara Hwang, MD

Henry Ford Hospital
Detroit, MI United States
  Connect »

Michael Zakem, DO

Metro Health Cancer Center
Wyoming, MI United States
  Connect »

Luke Nordquist, MD

GU Research Network, LLC
Omaha, NE United States
  Connect »

Shawn Zimberg, MD

Integrated Medical Professionals, PLLC
Lake Success, NY United States
  Connect »

Bagi Jana, MD

University of Texas Medical Branch at Galveston
Galveston, TX United States
  Connect »

Deepak Kilari, MD

Clement J. Zablocki VA Medical Center
Milwaukee, WI United States
  Connect »