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A Pilot Study of Parenteral Testosterone and Oral Etoposide as Therapy for Men With Castration Resistant Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01084759
First received: March 9, 2010
Last updated: April 5, 2016
Last verified: January 2016
Results First Received: December 17, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Testosterone injection
Drug: Etoposide

  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
Testosterone Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).

Participant Flow:   Overall Study
    Testosterone
STARTED   16 
COMPLETED   14 
NOT COMPLETED   2 



  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
Etoposide and Testosterone Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days.

Baseline Measures
   Etoposide and Testosterone 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Years]
Median (Full Range)
 71 
 (56 to 87) 
Gender 
[Units: Participants]
 
Female   0 
Male   16 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   4 
White   12 
More than one race   0 
Unknown or Not Reported   0 
Prostate Specific Antigen (PSA) 
[Units: ng/mL]
Median (Full Range)
 20 
 (1.4 to 819.1) 
Testosterone [1] 
[Units: ng/dL]
Median (Full Range)
 20 
 (20 to 41) 
[1] Note: The limit of detection for this assay is 20 ng/dL. Patients with an undetectable testosterone level were assigned a value of 20 ng/dL.
Baseline Gleason Grade (higher grade indicates more pathologic atypia) [1] 
[Units: Participants]
 
Gleason score 6   4 
Gleason score 7   7 
Gleason score 8   3 
Gleason score 9   2 
[1] Gleason score was based on clinical interpretation of the needle biopsy specimen or prostatectomy specimen by an expert pathologist.
Length of continuous androgen deprivation therapy 
[Units: Months]
Median (Full Range)
 45.5 
 (12 to 146) 
Number of second line hormonal therapies received [1] 
[Units: Participants]
 
None   2 
1 second line agent   9 
2 second line agents   3 
3 second line agents   2 
[1] Second line hormonal therapies were defined as any agent that inhibits androgen receptor (AR) signaling (e.g. AR antagonist, inhibitors of extragonadal testosterone synthesis).
Bone metastases 
[Units: Participants]
 
Patients with bone metastases   3 
Patients without bone metastases   13 
RECIST evaluable soft tissue metastases 
[Units: Participants]
 
Patients with RECIST evaluable disease   10 
Patients without RECIST evaluable disease   6 


  Outcome Measures
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1.  Primary:   Percentage of Patients Completing at Least 3 Months of Therapy With a PSA Below Baseline.   [ Time Frame: 3 months ]

2.  Primary:   Time to PSA Progression   [ Time Frame: 2 years ]

3.  Secondary:   Number of Participants With RECIST Response (i.e. Complete Response or Partial Response)   [ Time Frame: 2 years ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Samuel Denmeade
Organization: SKCCC at Johns Hopkins
phone: 410-955-8875
e-mail: denmesa@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01084759     History of Changes
Other Study ID Numbers: J09121, NA_00033419
Study First Received: March 9, 2010
Results First Received: December 17, 2015
Last Updated: April 5, 2016
Health Authority: United States: Institutional Review Board