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Studying the Medication Olaparib Given with Radium-223 for Advanced Prostate Cancer with Bone Metastasis

Studying the Medication Olaparib Given with Radium-223 for Advanced Prostate Cancer with Bone Metastasis

Clinicaltrials.gov identifier:
NCT03317392

Treatment
People with castration-resistant prostate cancer with bone spread

Study Contact Information:

Contact:  Rana R McKay  858-822-5354 or by email: rmckay@health.ucsd.edu        


Studying the Targeted Therapy Olaparib Given with Radium-223 for Advanced Prostate Cancer with Bone Metastasis

About the Study

This study is measuring the best dosage for and side effects of the drug combination Olaparib and radium-223 to treat men with , that has spread to the bones


Type of Study

 

This is a study with two separate treatment groups.      

Participants are placed into one of two study groups by chance, and neither the participants nor the researchers choose the group into which the participants are placed.

  • Group 1 participants will receive radium injection and oral olaparib.
  • Group 2 participants will receive radium injection only.

The study allows crossover. Participants in Group 2 whose cancer gets worse will be allowed to switch to Group 1 and receive olaparib.


What the Study Involves

  • The study involves up to 6 cycles of 28 days, for a total of 168 days. All participants will receive an injection of radium-223 into their vein, two times on day one, then again every 28 days.
    • Group 1 participants will also receive olaparib orally two times daily for the entire 168 day treatment period.      
    • Group 2 participants will not receive olaparib, unless their cancer gets worse. Participants in Group 2 whose cancer gets worse will be allowed to switch over to Group 1 to receive olaparib.       
  • Participants will be followed for up to two years for side effects, quality of life, and progression of disease.


Study Sites

California

  • San Diego, CA
    UC San Diego Moores Cancer Center Recruiting
    Contact: 858-822-5354 or by email: cancercto@ucsd.edu  
    Lead researcher: Rana R. McKay, MD
  • Sacramento, CA
    University of California Davis Comprehensive Cancer Center 
    Contact: 916-734-3089
    Lead researcher: Mamta Parikh, MD  

Kansas

  • Fairway, KS
    University of Kansas Clinical Research Center    
    Contact: 913-588-3671 or by email: KUCC_Navigation@kumc.edu
    Lead researcher: Rahul A. Parikh, MD
  • Kansas City, KS         
    University of Kansas Cancer Center
    Contact: 913-588-3671 or by email: KUCC_Navigation@kumc.edu
    Lead researcher: Rahul A. Parikh, MD 
  • Overland Park, KS         
    University of Kansas Cancer Center
    Contact: 913-588-3671 or by email: KUCC_Navigation@kumc.edu
    Lead researcher: Rahul A. Parikh, MD
  • Westwood, KS         
    University of Kansas Hospital-Westwood Cancer Center 
    Contact: 913-588-3671 or by email: KUCC_Navigation@kumc.edu
    Lead researcher: Rahul A. Parikh, MD

Maryland

  • Baltimore, MD
    University of Maryland/Greenebaum Cancer Center             
    Contact: 800-888-8823
    Lead researcher: Arif Hussain, MD     

Missouri

  • Creve Coeur, MO
    Siteman Cancer Center at West County Hospital
    Contact: 800-600-3606 or by email: info@siteman.wustl.edu
    Lead researcher: Hiram A. Gay, MD   
  • Kansas City, MO         
    University of Kansas Cancer Center - North
    Contact: 913-588-3671 or by email: KUCC_Navigation@kumc.edu
    Lead researcher: Rahul A. Parikh, MD   
  • Lee's Summit, MO         
    University of Kansas Cancer Center - North
    Contact: 913-588-3671 or by email: KUCC_Navigation@kumc.edu
    Lead researcher: Rahul A. Parikh, MD
  • Saint Louis, MO
    Washington University School of Medicine
    Contact: 800-600-3606 or by email: info@siteman.wustl.edu
    Lead researcher: Hiram A. Gay, MD  
  • Saint Louis, MO
    Siteman Cancer Center-South County 
    Contact: 800-600-3606 or by email: info@siteman.wustl.edu
    Lead researcher: Hiram A. Gay, MD
  • Saint Peters, MO
    Siteman Cancer Center at Saint Peters Hospital  
    Contact: 800-600-3606 or by email: info@siteman.wustl.edu
    Lead researcher: Hiram A. Gay, MD 

New Jersey

  • New Brunswick, NJ
    Rutgers Cancer Institute of New Jersey
    Contact: 732-235-7356
    Lead researcher: Biren Saraiya, MD    

Ohio

  • Columbus, OH
    Ohio State University Comprehensive Cancer Center           
    Contact: 800-293-5066 or by email: Jamesline@osumc.edu
    Lead researcher: Edmund Folefac, MD   

Pennsylvania

  • Pittsburgh, PA
    University of Pittsburgh Cancer Institute (UPCI)       
    Contact: 412-647-8073     
    Lead researcher: Adam Olson, MD 

Wisconsin

  • Madison, WI
    University of Wisconsin Carbone Cancer Center
    Contact: 800-622-8922     
    Lead researcher: Christos Kyriakopoulos   
This Study is Open To:

People age 18 years or older who meet all of the following criteria*:

  • Diagnosis of late , progressive cancer (adenocarcinoma only)
  • with low blood testosterone (<50 ng/dL)
  • Cancer spread () to the bones

*Contact your doctors or the study coordinators for a complete list of inclusion criteria.

This Study is Not Open To:

This study is not open to those who have*:

  • Spread of cancer to their liver, lung, brain or other soft tissue site
  • A type of cancer known as small cell carcinoma
  • Received prior treatment with radium-223
  • Received prior treatment with olaparib or another
  • Uncontrolled, non-cancer illness (such as congestive heart failure or hepatitis)
  • Received a prior bone marrow transplant
  • Blood disorders such as myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)

*Contact your doctors or the study coordinators for a complete list of exclusion criteria.