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Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT02135484
First received: May 8, 2014
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.


Condition Intervention
Prostate Cancer
Drug: Alpharadin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Observation, Open Label Study of Alpharadin (Radium 223) in Patients With Castrate Resistant Prostate Cancer Bone Metastases

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Biomarkers in Predicting Overall Survival [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Each marker tested individually using a Cox regression model to determine whether it is associated with overall survival. Overall survival (OS) measured as the number of months from enrollment until death. Markers measured on a continuous or ordinal scale included with their original units in the model. Baseline values used to determine if baseline is associated with survival. Percent change calculated from baseline and used as a continuous measure in the model. Ordered category of reduced by 30%, same, or increased by 30% grouping used in the model. All observed values of marker included as a time-varying covariate in the Cox regression model.


Estimated Enrollment: 25
Study Start Date: September 2014
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alpharadin
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
Drug: Alpharadin
50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
Other Names:
  • Xofigo
  • Radium-223 chloride
  • Radium-223 dichloride

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically proven adenocarcinoma of the prostate with evidence for skeletal metastases on bone scan and/or CT scan and symptoms judged to be related to bone metastases
  2. Eastern Cooperative Oncology Group (ECOG) performance status < 2. (Karnofsky Performance Status >/= 50%)
  3. Serum testosterone levels < 50ng/ml
  4. Ongoing gonadal androgen deprivation therapy with Luteinizing Hormone-Releasing Hormone (LHRH) analogues or orchiectomy. Patients, who have not had an orchiectomy, must be maintained on standard dosing of LHRH analogue therapy at appropriate frequency for the duration of the study
  5. Life expectancy of at least 12 weeks (3 months)
  6. Discontinue any steroids prescribed to specifically treat prostate cancer (for e.g as a secondary hormonal manipulation or for cord compression) > 4 weeks prior to study drug. Steroids chronically prescribed for a non-cancer-related illness [e.g. asthma or chronic obstructive pulmonary disease (COPD)] that is well controlled with medical management are permissible to an equivalent of <10 mg Prednisone daily. Note: Steroids may be administered during the study as supportive care
  7. Laboratory Requirements: a.) white blood cell (WBC) count > 3,000/ul; b.) Absolute Neutrophil Count (ANC) > 1,500/ul; c.) Hemoglobin >/= 8.0 g/dL independent of transfusion; d.) Platelet count >/= 100,000/uL; e.) Serum albumin >/= 3.0 g/dL; f.) Calculated or measured creatinine clearance > 30 mL/min
  8. All acute toxic effects of any prior treatment have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF)
  9. Patient must be willing and able to comply with protocol requirements. All patients must sign an informed consent indicating that they are aware of the investigational nature of this study
  10. Patients must also have signed an authorization for the release of their protected health information

Exclusion Criteria:

  1. Treatment with cytotoxic chemotherapy within previous 4 weeks of protocol treatment, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 4 weeks prior to protocol treatment (however, ongoing neuropathy is permitted)
  2. Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Ra-223 dichloride) for the treatment of bony metastases
  3. Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
  4. Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality)
  5. Known brain metastases
  6. Lymphadenopathy exceeding 6 cm in short-axis diameter
  7. Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
  8. Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression
  9. Any other serious illness or medical condition, such as but not limited to: a) Any infection >/= National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 2; b) Cardiac failure New York Heart Association (NYHA) III or IV; c) Crohn's disease or ulcerative colitis; d) Bone marrow dysplasia; e) Fecal incontinence
  10. Inability to comply with the protocol and/or not willing or not available for follow-up assessments
  11. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation
  12. Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than Ra 223 dichloride
  13. Prior use of Ra-223 dichloride, Strontium or Samarium
  14. Concurrent use of another investigational drug or device therapy (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form)
  15. Major surgery within 30 days prior to start of study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02135484

Contacts
Contact: John Araujo, MD, PHD 713-792-2830

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Bayer
Investigators
Principal Investigator: John Araujo, MD,PHD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02135484     History of Changes
Other Study ID Numbers: 2013-0933
Study First Received: May 8, 2014
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Prostate Cancer
Adenocarcinoma of the prostate
Castrate resistant prostate cancer
CRPC
Skeletal metastases
Alpharadin
Xofigo
Radium-223 chloride
Radium-223 dichloride

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014