Trial Outcomes & Findings for Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA) (NCT NCT01118741)
NCT ID: NCT01118741
Last Updated: 2018-06-12
Results Overview
For both of the doses explored (i.e. disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed. A demethylation response was defined as a \>=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.
COMPLETED
NA
19 participants
24 months
2018-06-12
Participant Flow
Recruitment dates: 06/04/2010 through 08/01/2011 in medical clinics
Given the toxic effects of disulfiram when administered within 14 days of ingesting ethanol, participants were required to agree not to drink alcohol during the study and for 14 days after its completion.
Participant milestones
| Measure |
Disulfiram Low Dose 250mg Dose
First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
|
Disulfiram High Dose 500mg Dose
After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Recurrent Prostate Cancer With Rising Prostate Specific Antigen (PSA)
Baseline characteristics by cohort
| Measure |
Disulfiram Low Dose 250mg Dose
n=9 Participants
First 9 subjects were assigned to the low dose arm
|
Disulfiram High Dose 500mg Dose
n=10 Participants
After 9 subjects were enrolled in the low dose arm, the high dose was opened.
|
Total
n=19 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
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
66.6 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
62.6 years
STANDARD_DEVIATION 3.4 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 5.6 • 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
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsFor both of the doses explored (i.e. disulfiram 250 mg PO daily and 500 mg PO daily) the proportion of subjects with a demethylation response was computed. A demethylation response was defined as a \>=10% decrease from baseline in global 5-methyl cytosine content as assessed from peripheral blood mononuclear cells.
Outcome measures
| Measure |
Disulfiram Low Dose 250mg Dose
n=9 Participants
First 9 subjects were assigned to the low dose arm
|
Disulfiram High Dose 500mg Dose
n=10 Participants
|
|---|---|---|
|
Proportion of Subjects With a Demethylation Response at Each Dose Level
|
.22 proportion of participants
Interval 0.03 to 0.6
|
.30 proportion of participants
Interval 0.07 to 0.65
|
SECONDARY outcome
Timeframe: Up to 6 monthsTo assess the clinical response measured by prostate specific antigen (PSA) progression at 6 months after treatment with the defined dose of disulfiram in prostate cancer (PCa) patients with evidence of biochemical relapse after local therapy. Reported as number of participants with PSA progression by 6 months. Criteria used to assess: A rise in PSA noted at 6 months, greater than 50% over PSA value at baseline and \> 2 ng/ml, above the nadir. The rise was confirmed by a second PSA value obtained at least 1 week from that reference value.
Outcome measures
| Measure |
Disulfiram Low Dose 250mg Dose
n=9 Participants
First 9 subjects were assigned to the low dose arm
|
Disulfiram High Dose 500mg Dose
n=10 Participants
|
|---|---|---|
|
Clinical Response
|
5 participants
|
0 participants
|
Adverse Events
Disulfiram Low Dose 250mg Dose
Disulfiram High Dose 500mg Dose
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Disulfiram Low Dose 250mg Dose
n=9 participants at risk
First 9 subjects were assigned to the low dose arm
|
Disulfiram High Dose 500mg Dose
n=10 participants at risk
After 9 subjects were enrolled in the low dose arm, the high dose was opened.
|
|---|---|---|
|
General disorders
FATIGUE
|
66.7%
6/9 • Number of events 6 • 7/16/10-9/27/11 (14 months)
|
80.0%
8/10 • Number of events 8 • 7/16/10-9/27/11 (14 months)
|
|
Ear and labyrinth disorders
HEARING LOSS
|
11.1%
1/9 • Number of events 1 • 7/16/10-9/27/11 (14 months)
|
0.00%
0/10 • 7/16/10-9/27/11 (14 months)
|
|
Gastrointestinal disorders
TASTE ALTERATION
|
22.2%
2/9 • Number of events 2 • 7/16/10-9/27/11 (14 months)
|
40.0%
4/10 • Number of events 4 • 7/16/10-9/27/11 (14 months)
|
|
Eye disorders
DIPLOPIA
|
11.1%
1/9 • Number of events 1 • 7/16/10-9/27/11 (14 months)
|
0.00%
0/10 • 7/16/10-9/27/11 (14 months)
|
|
Investigations
ALT
|
11.1%
1/9 • Number of events 1 • 7/16/10-9/27/11 (14 months)
|
0.00%
0/10 • 7/16/10-9/27/11 (14 months)
|
|
Gastrointestinal disorders
DIARRHEA
|
11.1%
1/9 • Number of events 1 • 7/16/10-9/27/11 (14 months)
|
30.0%
3/10 • Number of events 3 • 7/16/10-9/27/11 (14 months)
|
|
Gastrointestinal disorders
CONSTIPATION
|
22.2%
2/9 • Number of events 2 • 7/16/10-9/27/11 (14 months)
|
20.0%
2/10 • Number of events 2 • 7/16/10-9/27/11 (14 months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place