Last updated on July 2018

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

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

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

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

IU Health Central Indiana Cancer Centers
Indianapolis, IN United States

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

University of Michigan Health System
Ann Arbor, MI United States

Henry Ford Hospital
Detroit, MI United States

Metro Health Cancer Center
Wyoming, MI United States

GU Research Network, LLC
Omaha, NE United States

Integrated Medical Professionals, PLLC
Lake Success, NY United States

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

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