Pre-Prostatectomy Lovastatin on Prostate Cancer

This study has suspended participant recruitment.
(The study was stopped due to an unanticipated serious adverse event.)
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01478828
First received: November 3, 2011
Last updated: October 13, 2015
Last verified: October 2015
Results First Received: January 13, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Cancer
Intervention: Drug: Lovastatin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lovastatin After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.

Participant Flow:   Overall Study
    Lovastatin  
STARTED     2  
COMPLETED     1  
NOT COMPLETED     1  
Adverse Event                 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
Lovastatin

After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.

Lovastatin: oral qd varying dose escalations/de-escalations


Baseline Measures
    Lovastatin  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     0  
Gender, Customized  
[units: participants]
 
Male     2  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants That Can Achieve 60% MYC Modulation Response   [ Time Frame: 1 year ]

2.  Secondary:   Number of Participants Who Experience Specific Adverse Events at Different Dosing Points Prior to Surgery.   [ Time Frame: 1 year ]

3.  Secondary:   To Estimate What the Doses Given to Men With MYC Target Inhibition When Factoring in Their Tumor Biopsies Before and After Lovastatin Treatment.   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Number and Type of Cholesterol Changes After Lovastatin Treatments.   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Capture the Pharmacodynamic Changes in Participants After the Pre-treatment Biopsy.   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Capture the Associated Changes in Participants With Regards to the Relationship Between MYC and Increased Apoptosis.   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Number of Participants Who Follow All of the Study Rules.   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Capture Difference in MYC Downregulation Between Treated Participants and Non-treated Patients   [ Time Frame: 1 year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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. Phuoc Tran
Organization: The SKCCC at Johns Hopkins
phone: 410-614-6477
e-mail: tranp@jhmi.edu



Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01478828     History of Changes
Other Study ID Numbers: J-1153
NA_00048234 ( Other Identifier: Johns Hopkins University School of Medicine )
Study First Received: November 3, 2011
Results First Received: January 13, 2015
Last Updated: October 13, 2015
Health Authority: United States: Institutional Review Board