Trial Outcomes & Findings for Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer (NCT NCT02217709)
NCT ID: NCT02217709
Last Updated: 2026-06-25
Results Overview
A \>= 50% decline in prostate-specific antigen (PSA) from baseline is a significant indicator of a positive treatment response in prostate cancer, associated with a lower risk of disease progression and improved survival.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline to up to 12 months
Results posted on
2026-06-25
Participant Flow
Recruitment for this study opened in September 2014 and closed in April 2019. All subjects were seen and treated in the medical clinics at the University of Southern California, Los Angeles General Medical Center, and Westside Prostate Cancer Center.
Participant milestones
| Measure |
Treatment (Phenelzine Sulfate)
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Treatment (Phenelzine Sulfate)
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
Baseline Characteristics
Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Phenelzine Sulfate)
n=26 Participants
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 12 monthsA \>= 50% decline in prostate-specific antigen (PSA) from baseline is a significant indicator of a positive treatment response in prostate cancer, associated with a lower risk of disease progression and improved survival.
Outcome measures
| Measure |
Treatment (Phenelzine Sulfate)
n=20 Participants
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Number of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate
|
1 Participants
|
PRIMARY outcome
Timeframe: Baseline to up to 12 monthsA PSA decline of \>=30% or more from the baseline is a strong predictor of a positive clinical outcome for many types of cancer, especially for advanced prostate cancer. Patients with this level of PSA reduction typically have longer overall survival and a delayed time to disease progression compared to those who do not experience this decline.
Outcome measures
| Measure |
Treatment (Phenelzine Sulfate)
n=20 Participants
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Number of Patients With PSA Decline of >= 30% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate
|
4 Participants
|
SECONDARY outcome
Timeframe: Through 30 days after the last dose of study drug, up to 3 yearsAnalyses of safety/ toxicity will be performed for all patients having received at least one dose of study drug. The study will use the CTCAE version 4 for reporting of hematologic and non-hematologic adverse events.
Outcome measures
| Measure |
Treatment (Phenelzine Sulfate)
n=20 Participants
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Percent of Common Toxicities Observed
dizziness, grade 1
|
45 percentage of participants
|
|
Percent of Common Toxicities Observed
dizziness, grade 2
|
35 percentage of participants
|
|
Percent of Common Toxicities Observed
hypertension, grade ≥ 2
|
30 percentage of participants
|
|
Percent of Common Toxicities Observed
edema, grade 1
|
25 percentage of participants
|
|
Percent of Common Toxicities Observed
edema, grade 2
|
10 percentage of participants
|
SECONDARY outcome
Timeframe: Through study completion, up to 3 years.Outcome measures
| Measure |
Treatment (Phenelzine Sulfate)
n=20 Participants
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Time to Radiographic Disease Progression for Patients With Recurrent Prostate Cancer Treated With Phenelzine.
|
NA Months
We used Kaplan Meier method to estimate the probability time to progression. Median of time to progression is the time point when 50% of the subjects experienced progression. If we observe less than 50% of subjects experienced progression, we will say the median of survival or time to progression or treatment failure is not reached.
|
Adverse Events
Treatment (Phenelzine Sulfate)
Serious events: 8 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Treatment (Phenelzine Sulfate)
n=26 participants at risk
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Investigations
Weight gain
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Nervous system disorders
Syncope
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Vascular disorders
Hypertension
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
Other adverse events
| Measure |
Treatment (Phenelzine Sulfate)
n=26 participants at risk
Patients receive phenelzine sulfate 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade \< or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue in the absence of disease progression or unacceptable toxicity.
phenelzine sulfate: Given by mouth
laboratory biomarker analysis: Correlative studies
questionnaire administration: Ancillary studies
|
|---|---|
|
Vascular disorders
Hypotension
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Psychiatric disorders
Insomnia
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Vascular disorders
Hypertension
|
15.4%
4/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Eye disorders
Blurred Vision
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
11.5%
3/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Diarrhea
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Dry mouth
|
26.9%
7/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Gastrointestinal disorders
Stomach pain
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
General disorders
Edema limbs
|
26.9%
7/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
General disorders
Fatigue
|
30.8%
8/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Investigations
Aspartate aminotransferase increased
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Investigations
Weight gain
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Nervous system disorders
Dizziness
|
61.5%
16/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Nervous system disorders
Headache
|
11.5%
3/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Nervous system disorders
Memory impairment
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Nervous system disorders
Movements involuntary
|
11.5%
3/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Nervous system disorders
Somnolence
|
23.1%
6/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Nervous system disorders
Tremor
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Psychiatric disorders
Agitation
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Psychiatric disorders
Anorgasmia
|
7.7%
2/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Psychiatric disorders
Anxiety
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Psychiatric disorders
Confusion
|
23.1%
6/26 • Through 30 days after final dose of study drug, up to 3 years.
|
|
Psychiatric disorders
Depression
|
3.8%
1/26 • Through 30 days after final dose of study drug, up to 3 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place