Trial Outcomes & Findings for Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer (NCT NCT00809458)
NCT ID: NCT00809458
Last Updated: 2015-07-16
Results Overview
PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.
TERMINATED
PHASE3
15 participants
30 days
2015-07-16
Participant Flow
Patients were recruited at oncology clinics between December 2008 and April 2010. The study was terminated due to low accrual rate.
One subject suffered an unrelated bone fracture prior to study start, and another was determined to have metastatic disease. 71 participants were screened. 31 did not meet criteria; 25 refused study entry. 15 were enrolled
Participant milestones
| Measure |
Arm 1 (Vitamin E)
Vitamin E administration: one 400 IU tablet of vitamin E daily
|
Arm 2 (Placebo)
Placebo (same vehicle as used for vitamin E): one placebo tablet daily
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
6
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarker Study of Neoadjuvant Vitamin E in Patients With Locally Treatable Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Vitamin E)
n=9 Participants
Vitamin E administration: one 400 IU tablet of vitamin E daily
|
Arm 2 (Placebo)
n=6 Participants
Placebo (same vehicle as used for vitamin E): one placebo tablet daily
|
Total
n=15 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
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
60.5 years
n=7 Participants
|
60 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
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.
PSA levels will be measured as a sensitive marker of anti-androgenic activity that is a critical endpoint to be measured in this study. PSA blood levels will be determined at the initiation and completion of Vitamin E supplementation from blood obtained at these time points. A clinical reference laboratory will perform blood PSA analysis and will be compared with plasma cholesterol levels as a relative control.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.
1. Cardiovascular Effects/ Thrombophlebitis 2. Dermatologic Effects 3. Gastrointestinal Effects (Gingival bleeding, and gastrointestinal irritations including: diarrhea, nausea, flatulence and stomach cramps) 4. Hematologic Effects (Increased bleeding tendencies in vitamin K deficient patients; inhibition of prothrombin production 5. Hepatic Effects (Vasculopathic hepatotoxicity and cholestasis) 6. Neurologic Effects (Dizziness, headache, fatigue or weakness 7. Ophthalmic Effects ( Blurred vision) 8. Respiratory Effects (Pulmonary embolism)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsPopulation: This study was terminated early due to low accrual. No participants were analyzed for this outcome measure because the study was terminated. There are no data to report.
The correlation between the ATQ level and the androgen receptor will be explored.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1 (Vitamin E)
Arm 2
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 (Vitamin E)
n=9 participants at risk
Vitamin E
Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.
|
Arm 2
n=6 participants at risk
Placebo (same vehicle as used for vitamin E)
Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy.
|
|---|---|---|
|
Cardiac disorders
Hypotension (Low blood pressure)
|
11.1%
1/9 • Number of events 1 • Subjects were followed from the start of treatment until 30 days after prostatectomy or brachytherapy.
|
0.00%
0/6 • Subjects were followed from the start of treatment until 30 days after prostatectomy or brachytherapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place