Radium-223 Dichloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

July 11, 2014 updated by: Bayer

Radium-223 Chloride (BAY88-8223) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC patients diagnosed with symptomatic bone metastasis and to collect additional short and long term safety data on the product.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
    • Arizona
      • Phoenix, Arizona, United States, 85040
      • Scottsdale, Arizona, United States, 85260
    • California
      • Greenbrae, California, United States, 94904
      • La Jolla, California, United States, 92093
      • San Francisco, California, United States, 94143
      • Stanford, California, United States, 94305
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Delaware
      • Newark, Delaware, United States, 19718
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
      • Washington, District of Columbia, United States, 20060
    • Florida
      • Fort Myers, Florida, United States, 33901
      • Miami Beach, Florida, United States, 33140
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Hawaii
      • Honolulu, Hawaii, United States, 96813-2413
    • Indiana
      • Goshen, Indiana, United States, 46526
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
      • Shreveport, Louisiana, United States, 71103
    • Maryland
      • Baltimore, Maryland, United States, 21287
      • Baltimore, Maryland, United States, 21229
      • Baltimore, Maryland, United States, 21201-1595
      • Bethesda, Maryland, United States, 20889
      • Rockville, Maryland, United States, 20850
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02114
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0028
      • Detroit, Michigan, United States, 48201
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
    • Missouri
      • St. Louis, Missouri, United States, 63110
    • Nevada
      • Las Vegas, Nevada, United States, 89169
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903-2681
      • Newark, New Jersey, United States, 07103
    • New York
      • New Hyde Park, New York, United States, 11040-1496
      • New York, New York, United States, 10016
      • New York, New York, United States, 10065
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Raleigh, North Carolina, United States, 27607
    • Ohio
      • Cleveland, Ohio, United States, 44195
      • Columbus, Ohio, United States, 43212
    • Oregon
      • Springfield, Oregon, United States, 97477
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19111-2497
      • Philadelphia, Pennsylvania, United States, 19401
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
      • Myrtle Beach, South Carolina, United States, 29577
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Houston, Texas, United States, 77030
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78229
      • Temple, Texas, United States, 76508
    • Virginia
      • Hampton, Virginia, United States, 23666
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Seattle, Washington, United States, 98122
    • West Virginia
      • Wheeling, West Virginia, United States, 26003
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226-3596

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Histologically or cytologically confirmed prostate cancer
  • Patients diagnosed with symptomatic progressive bone predominant metastatic CRPC/HRPC with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)

  • Symptomatic is defined as either

    • Regular (not occasional) use of analgesic medication for cancer related bone pain (≥ level 1; World Health Organization [WHO] ladder for cancer pain), or
    • Treatment with external beam radiation therapy (EBRT) for bone pain (the EBRT should be within the last 12 weeks before treatment)

  • Progressive disease is defined either by:

    • The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), then PSA values from 3 assessments within the last 6 months must be provided; OR
    • In the absence of new bone lesions, 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but, the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met).
  • No intention to use cytotoxic chemotherapy within the next 6 months
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2

  • Adequate hematological, liver, and renal function

    • Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
    • Platelet count ≥ 100 x10^9/L
    • Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN
    • Albumin > 25 g/L *Any bone imaging techniques as per institutional standard of care

Exclusion Criteria:

  • Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
  • Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
  • Treatment with cytotoxic chemotherapy within previous 4 weeks prior to screening, or failure to recover from adverse events (AEs) due to cytotoxic chemotherapy administered more than 4 weeks previous prior to screening (however, ongoing neuropathy is permitted)
  • Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count, and platelets
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
  • Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
  • Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
  • Presence of brain metastases
  • Lymphadenopathy exceeding 6 cm in short-axis diameter
  • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
  • Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.

  • Any other serious illness or medical condition, such as but not limited to:

    • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
    • Cardiac Failure New York Heart Association (NYHA) Class III or IV
    • Crohn's disease or ulcerative colitis
    • Bone marrow dysplasia
  • Fecal incontinence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 20, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Estimate)

July 14, 2014

Last Update Submitted That Met QC Criteria

July 11, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15995
  • 2011-004469-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on Radium-223 dichloride (BAY88-8223)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Djibouti

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe