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Rapid Hormonal Cycling as Treatment for Patients With Prostate Cancer: The Men's Cycle

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00586898
First received: December 21, 2007
Last updated: February 24, 2016
Last verified: February 2016
Results First Received: December 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Prostate
Cancer
Hormonal Cycling
Interventions: Drug: GnRH
Drug: Ketoconazole
Drug: Bicalutamide
Drug: Testosterone transdermal gel
Drug: Estrogen transdermal patch

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Participants Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer

Participant Flow:   Overall Study
    All Participants
STARTED   36 
COMPLETED   29 
NOT COMPLETED   7 
Adverse Event                1 
Patiemt Non-compliance                1 
Evaluable for Toxicity Only                5 



  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.
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Reporting Groups
  Description
All Participants Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 36 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   16 
>=65 years   20 
Gender 
[Units: Participants]
 
Female   0 
Male   36 


  Outcome Measures

1.  Primary:   Response   [ Time Frame: 6 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: Dr. Howard Scher
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-422-4323
e-mail: Scherh@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00586898     History of Changes
Other Study ID Numbers: 01-085
Study First Received: December 21, 2007
Results First Received: December 16, 2015
Last Updated: February 24, 2016
Health Authority: United States: Food and Drug Administration