Trial Outcomes & Findings for Digoxin for Recurrent Prostate Cancer (NCT NCT01162135)
NCT ID: NCT01162135
Last Updated: 2025-05-04
Results Overview
Proportion of patients at 6 months post-treatment with a PSADT \>= 200% from baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
6 months after treatment with digoxin
Results posted on
2025-05-04
Participant Flow
Participant milestones
| Measure |
Digoxin
Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Digoxin
Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Severe back pain
|
1
|
|
Overall Study
Ineligible
|
1
|
Baseline Characteristics
Digoxin for Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Digoxin
n=16 Participants
Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after treatment with digoxinProportion of patients at 6 months post-treatment with a PSADT \>= 200% from baseline
Outcome measures
| Measure |
Digoxin
n=13 Participants
Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Rate of Positive PSADT Outcome
|
5 participants
|
Adverse Events
Digoxin
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digoxin
n=16 participants at risk
Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Dizziness
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Change in taste
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperkalemia
|
12.5%
2/16 • Number of events 4
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
18.8%
3/16 • Number of events 6
|
|
Blood and lymphatic system disorders
Hypoglycemia
|
6.2%
1/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Incontinence
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Decreased appetite
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Cold/cough
|
18.8%
3/16 • Number of events 3
|
|
Reproductive system and breast disorders
Testicular soreness
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Hematuria
|
12.5%
2/16 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphopenia
|
6.2%
1/16 • Number of events 1
|
|
Hepatobiliary disorders
ALT high
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Fatigue
|
18.8%
3/16 • Number of events 3
|
|
Blood and lymphatic system disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Hyperbilirubinemia
|
6.2%
1/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Bicarbonate low
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Edema
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Loose stools
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Decreased energy
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Lightheadedness
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Neck pain
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Arm pain
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Epigastric discomfort
|
6.2%
1/16 • Number of events 1
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Foot pain
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Numbness/cramping of lower legs
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1
|
|
Renal and urinary disorders
Urinary tract infection
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Nausea
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Hypertension
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Headaches
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Back pain
|
12.5%
2/16 • Number of events 3
|
|
General disorders
Vivid dreams
|
18.8%
3/16 • Number of events 3
|
|
Renal and urinary disorders
Nocturia
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Insomnia
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Low libido
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
12.5%
2/16 • Number of events 2
|
|
General disorders
Side pain
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Heart palpitations
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
EKG change
|
18.8%
3/16 • Number of events 4
|
|
General disorders
Rib pain
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Shoulder pain
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Indigestion
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Tooth root canal
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Difficulty raking deep breaths
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Nightmares
|
6.2%
1/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Boil on finger
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Acid reflux
|
6.2%
1/16 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Knee achiness
|
6.2%
1/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Poison ivy
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Sinus brachycardia
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place