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Trial record 47 of 278 for:    prostate cancer AND localized | ( Map: United States )

Pre-Prostatectomy Lovastatin on Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01478828
Recruitment Status : Terminated (The study was stopped due to an unanticipated serious adverse event.)
First Posted : November 23, 2011
Results First Posted : November 9, 2015
Last Update Posted : March 27, 2019
Sponsor:
Collaborator:
Patrick C Walsh Prostate Cancer Research Fund
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
Intervention Drug: Lovastatin
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lovastatin
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Lovastatin
Hide Arm/Group Description

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

Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
2
 100.0%
>=65 years
0
   0.0%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Male Number Analyzed 2 participants
2
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants
2
 100.0%
1.Primary Outcome
Title Number of Participants That Can Achieve 60% MYC Modulation Response
Hide Description Number of participants who achieve V-myc Myelocytomatosis Viral Oncogene Homolog (MYC) down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lovastatin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Number of Participants Who Experience Specific Adverse Events at Different Dosing Points Prior to Surgery.
Hide Description Toxicity of the different doses of continuous daily oral lovastatin in generally healthy men with prostate cancer prior to surgery.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to early study termination.
Arm/Group Title Lovastatin
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Proportion of Men With MYC Target Inhibition in Prostate Tumor Tissue
Hide Description Proportion of men with MYC target inhibition in prostate tumor tissue using paired tumor biopsies before and after lovastatin administration.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to early study termination.
Arm/Group Title Lovastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Cholesterol Level After Lovastatin Treatments.
Hide Description Change in cholesterol level with each tested dose of oral lovastatin.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to early study termination.
Arm/Group Title Lovastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pharmacodynamic Changes in Participants After the Pre-treatment Biopsy as Measured by Number of Participants With Target Inhibition of MYC
Hide Description Number of participants with target inhibition of MYC in relationship with pretreatment prostate biopsy Gleason sum, Ki-67, and degree of MYC overexpression.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to early study termination.
Arm/Group Title Lovastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Participants With Target Inhibition of MYC and Increased Apoptosis and Proliferation
Hide Description Number of participants with target inhibition of MYC and markers of increased apoptosis (cleaved caspase-3) and proliferation (Ki-67).
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to early study termination.
Arm/Group Title Lovastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Study Compliance as Assessed by Number of Participants Who Follow All of the Study Rules.
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to early study termination.
Arm/Group Title Lovastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Number of Participants With MYC Downregulation
Hide Description Number of participants with MYC downregulation after high-dose lovastatin.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this outcome measure due to early study termination.
Arm/Group Title Lovastatin
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame up to 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lovastatin
Hide Arm/Group Description 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.
All-Cause Mortality
Lovastatin
Affected / at Risk (%)
Total   0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lovastatin
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Musculoskeletal and connective tissue disorders   
rhabdomyolysis  [1]  1/2 (50.00%)  1
Indicates events were collected by systematic assessment
[1]
patient was diagnosed with profound rhabdomyolysis with CK values in excess of 100,000 IU/L.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lovastatin
Affected / at Risk (%) # Events
Total   0/2 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Phuoc Tran
Organization: The SKCCC at Johns Hopkins
Phone: 410-614-6477
EMail: tranp@jhmi.edu
Layout table for additonal information
Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT01478828     History of Changes
Other Study ID Numbers: J1153
NA_00048234 ( Other Identifier: JHM IRB )
First Submitted: November 3, 2011
First Posted: November 23, 2011
Results First Submitted: January 13, 2015
Results First Posted: November 9, 2015
Last Update Posted: March 27, 2019