Trial Outcomes & Findings for Statin Therapy Versus Placebo Prior to Prostatectomy (NCT NCT00572468)
NCT ID: NCT00572468
Last Updated: 2017-07-13
Results Overview
Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
5 years
Results posted on
2017-07-13
Participant Flow
Participant milestones
| Measure |
Simvastatin
Participants were randomized into the Simvastatin arm of this trial.
|
Placebo
Participants were randomized into the placebo arm of this trial.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
20
|
|
Overall Study
COMPLETED
|
20
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Statin Therapy Versus Placebo Prior to Prostatectomy
Baseline characteristics by cohort
| Measure |
Simvastatin
n=20 Participants
Participants were randomized into the Simvastatin arm of this trial.
|
Placebo
n=16 Participants
Participants were randomized into the placebo arm of this trial.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 Years
n=5 Participants
|
60.75 Years
n=7 Participants
|
60.56 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
16 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.
Measure the effect of pre-operative simvastatin versus placebo on the mevalonate pathway synthesis and target activation in benign and malignant prostate tissue using Androgen Receptor (AR) antibody. AR was measured in tissue obtained at the time of prostatectomy in both benign and malignant tissues.
Outcome measures
| Measure |
Simvastatin
n=15 Participants
Participants were randomized into the Simvastatin arm of this trial.
|
Placebo
n=11 Participants
Participants were randomized into the placebo arm of this trial.
|
|---|---|---|
|
Measure the Effect of Pre-operative Simvastatin Versus Placebo on the Mevalonate Pathway Synthesis and Target Activation in Benign and Malignant Prostate Tissue.
|
168.6666667 Percentage of cells
Interval 142.4517 to 194.882
|
182.7272727 Percentage of cells
Interval 161.46353 to 203.99107
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: We enrolled a total of 42 subjects, 36 completed this study. Of the 36 subjects who completed this study, only 26 subjects had tissue available for this analysis.
Compare the effect of pre-operative simvastatin versus placebo on prostate cancer cell apoptosis and its mediators in men undergoing planned prostatectomy. Apoptosis was measured by calculating the percent of Ki67 cellular staining.
Outcome measures
| Measure |
Simvastatin
n=15 Participants
Participants were randomized into the Simvastatin arm of this trial.
|
Placebo
n=11 Participants
Participants were randomized into the placebo arm of this trial.
|
|---|---|---|
|
Compare the Effect of Pre-operative Simvastatin Versus Placebo on Prostate Cancer Cell Apoptosis and Its Mediators in Men Undergoing Planned Prostatectomy.
|
7.53333 Percentage of cells
Interval 3.95134 to 11.11532
|
6 Percentage of cells
Interval 1.87843 to 10.12157
|
Adverse Events
Simvastatin
Serious events: 11 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simvastatin
n=20 participants at risk
Participants were randomized into the Simvastatin arm of this trial.
|
Placebo
n=16 participants at risk
Participants were randomized into the placebo arm of this trial.
|
|---|---|---|
|
Renal and urinary disorders
UTI
|
20.0%
4/20 • Number of events 4 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
6.2%
1/16 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
|
Cardiac disorders
Hypotension
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
6.2%
1/16 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
|
Reproductive system and breast disorders
Penile pain
|
15.0%
3/20 • Number of events 3 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
0.00%
0/16 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
|
Infections and infestations
Wound infection
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
0.00%
0/16 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
6.2%
1/16 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
|
Renal and urinary disorders
Catheter discomfort
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
6.2%
1/16 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
|
Infections and infestations
Bloody drainage from wound
|
5.0%
1/20 • Number of events 1 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
0.00%
0/16 • Adverse events were collected at baseline, weekly while on treatment, and at 30-day follow-up. Subjects were on trial for 4-8 weeks (depending on prostatectomy scheduling).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place