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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01084759
Recruitment Status : Completed
First Posted : March 10, 2010
Results First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: Testosterone injection
Drug: Etoposide

  Participant Flow

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
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

  Baseline Characteristics

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
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]
[Units: Years]
Median (Full Range)
 (56 to 87) 
[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)
 (1.4 to 819.1) 
Testosterone [1] 
[Units: ng/dL]
Median (Full Range)
 (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)
 (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

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

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

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

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Identifier: NCT01084759     History of Changes
Other Study ID Numbers: J09121, NA_00033419
First Submitted: March 9, 2010
First Posted: March 10, 2010
Results First Submitted: December 17, 2015
Results First Posted: May 9, 2016
Last Update Posted: May 9, 2016