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Hormone Ablation Therapy, Doxorubicin, and Zoledronate With or Without Strontium 89 in Treating Patients With Androgen-Dependent Prostate Cancer and Bone Metastases

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00081159
First received: April 7, 2004
Last updated: September 22, 2016
Last verified: September 2016
Results First Received: September 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Cancer
Prostate Cancer
Interventions: Drug: Doxorubicin hydrochloride
Drug: Goserelin acetate
Drug: Leuprolide acetate
Drug: Zoledronic acid
Procedure: orchiectomy
Radiation: strontium chloride Sr

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: July 6, 2004 to July 5, 2007. Recruitment done in medical clinic settings.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant of 80 male participants withdrew consent after the screening procedures therefore was not randomized nor treated and is excluded from the trial.

Reporting Groups
  Description
HAT, Doxorubicin, Zoledronate + Strontium Chloride Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin intravenous (IV) on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
HAT, Doxorubicin + Zoledronate Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.

Participant Flow:   Overall Study
    HAT, Doxorubicin, Zoledronate + Strontium Chloride   HAT, Doxorubicin + Zoledronate
STARTED   39   40 
COMPLETED   37   35 
NOT COMPLETED   2   5 
Withdrawal by Subject                0                3 
Myelosuppression prior to treatment                0                1 
Lost to Follow-up                2                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HAT, Doxorubicin, Zoledronate + Strontium Chloride Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
HAT, Doxorubicin + Zoledronate Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
Total Total of all reporting groups

Baseline Measures
   HAT, Doxorubicin, Zoledronate + Strontium Chloride   HAT, Doxorubicin + Zoledronate   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   40   79 
Age 
[Units: Years]
Median (Full Range)
 62 
 (46 to 77) 
 63 
 (46 to 82) 
 63 
 (46 to 82) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   39   40   79 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   37   34   71 
Black   2   3   5 
Not Reported   0   3   3 
Region of Enrollment 
[Units: Participants]
     
United States   39   40   79 


  Outcome Measures
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1.  Primary:   Progression Free Survival (PFS)   [ Time Frame: Up to 90 months with evaulation in 4 week intervals for up to 6 months of treatment, then follow up until disease progression ]

2.  Secondary:   Major Bone Scan Response   [ Time Frame: Week 13 ]

3.  Other Pre-specified:   Overall Survival (OS)   [ Time Frame: Up to 90 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Shi-Ming Tu, MD
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 1-877-632-6789
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00081159     History of Changes
Other Study ID Numbers: 2003-0922
MDA-2003-0922
NCI-6459
NCI-2009-00062 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
CDR0000360625 ( Other Identifier: NCI )
2U10CA045809-17 ( US NIH Grant/Contract Award Number )
Study First Received: April 7, 2004
Results First Received: September 22, 2016
Last Updated: September 22, 2016
Health Authority: United States: Institutional Review Board