Trial Outcomes & Findings for Pre-Prostatectomy Lovastatin on Prostate Cancer (NCT NCT01478828)
NCT ID: NCT01478828
Last Updated: 2019-03-27
Results Overview
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.
TERMINATED
NA
2 participants
1 year
2019-03-27
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Pre-Prostatectomy Lovastatin on Prostate Cancer
Baseline characteristics by cohort
| Measure |
Lovastatin
n=2 Participants
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
|
|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearNumber of participants who achieve V-myc Myelocytomatosis Viral Oncogene Homolog (MYC) down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.
Outcome measures
| Measure |
Lovastatin
n=2 Participants
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.
|
|---|---|
|
Number of Participants That Can Achieve 60% MYC Modulation Response
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to early study termination.
Toxicity of the different doses of continuous daily oral lovastatin in generally healthy men with prostate cancer prior to surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to early study termination.
Proportion of men with MYC target inhibition in prostate tumor tissue using paired tumor biopsies before and after lovastatin administration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to early study termination.
Change in cholesterol level with each tested dose of oral lovastatin.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to early study termination.
Number of participants with target inhibition of MYC in relationship with pretreatment prostate biopsy Gleason sum, Ki-67, and degree of MYC overexpression.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to early study termination.
Number of participants with target inhibition of MYC and markers of increased apoptosis (cleaved caspase-3) and proliferation (Ki-67).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: Data was not collected for this outcome measure due to early study termination.
Number of participants with MYC downregulation after high-dose lovastatin.
Outcome measures
Outcome data not reported
Adverse Events
Lovastatin
Serious adverse events
| Measure |
Lovastatin
n=2 participants at risk
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.
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|---|---|
|
Musculoskeletal and connective tissue disorders
rhabdomyolysis
|
50.0%
1/2 • Number of events 1 • up to 1 year
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place