CompletedNCT02217709Updated Jun 25, 2026Results posted

Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer

A Phase 2 interventional study of phenelzine sulfate and laboratory biomarker analysis in Adenocarcinoma of the Prostate, Recurrent Prostate Cancer and Stage I Prostate Cancer, sponsored by University of Southern California. Completed at 4 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by University of Southern California · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 26
Allocation: Not applicable
Ages: 18 Years and older
Sex: Male

Study summary

This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of antidepressant that works by decreasing the amount of a protein called monoamine oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC) treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA) decline of >= 50% from baseline.

SECONDARY OBJECTIVES:

I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine in prostate cancer patients.

II. To assess time to radiographic disease progression for patients with recurrent prostate cancer treated with phenelzine.

EXPLORATIORY OBJECTIVES:

I. To collect blood and other samples to study the relationship between MAO activity, biomarkers and prostate cancer.

OUTLINE:

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.

After completion of study treatment, patients are followed up every 3 months for up to 3 years.

Conditions studied

Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer

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Prostatic Neoplasms 6,367

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's enrollment of 26 is below the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.

Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

Histologically confirmed adenocarcinoma of the prostate
Recurrent prostate cancer following primary therapy as defined by:
- Post-radical prostatectomy: Any PSA >= 0.4 ng/ml
- Post-primary radiotherapy: PSA >= 2 ng/ml above a post-radiotherapy nadir
- Post-primary androgen-deprivation therapy: A confirmed rise of PSA >= 2 ng/ml above a post-therapy nadir
For patients with non-castrate levels of circulating androgen levels (testosterone >= 50 g/dl)
- PSA levels should be increasing on at least two occasions >= 1 week apart
- Patients should not be considered candidates for radiation therapy
For patients with castrate levels of circulating androgen levels (testosterone \< 50 ng/dl):
- PSA levels must be >= 0.4 ng/ml (if history of radical prostatectomy) or >= 2 ng/ml (if history of non-surgical primary treatment) and found to be increasing on at least two occasions >= 1 week apart
At least 4 weeks must have elapsed since any changes to hormonal therapy, including at least 4 weeks since flutamide and at least 6 weeks since bicalutamide, nilutamide, or enzalutamide
No evidence of metastatic cancer on imaging including a bone scan and computed tomography (CT) scan of chest/abdomen/pelvis
Able to understand and adhere to dietary and medication restrictions as recommended for the safe use of phenelzine
Men with child bearing potential are required to use an effective means of contraception
Leukocytes >= 3,000/mcL
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin =\< 1.5 x upper limit of normal (ULN) except in cases of benign isolated hyperbilirubinemia such as Gilbert's syndrome.
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SPGT]) =\< 2.5 x ULN
Creatinine =\< 1.5 x ULN

Exclusion criteria

Exclusion Criteria:

Uncontrolled hypertension despite appropriate medical therapy (blood pressure [BP] greater than 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit); Note: patients may be rescreened after adjustment of antihypertensive medications
Known prior history of mania or major psychiatric illness (schizophrenia, bipolar disorder, severe major depression requiring hospitalization, etc.)
Concurrent use of medications contra-indicated due to potential interactions with phenelzine
Inability to comply with dietary restrictions for foods, supplements, and medications with potential for adverse interactions with phenelzine or to otherwise cooperate fully with the investigator and study personnel
History of allergic reactions attributed to compounds of similar chemical or biologic composition to phenelzine or other monoamine oxidase inhibitors
Patients may not be receiving any other investigational agents
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 26 participants (actual)

Study arms

Experimental
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.
Drug: phenelzine sulfate · Other: laboratory biomarker analysis · Other: questionnaire administration

Interventions

Drugphenelzine sulfate
Given by mouth
Also known as: Nardil
Otherlaboratory biomarker analysis
Correlative studies
Otherquestionnaire administration
Ancillary studies

What researchers measure

Primary outcomes

Number of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate
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.
Time frame: Baseline to up to 12 months
Number of Patients With PSA Decline of >= 30% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate
A 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.
Time frame: Baseline to up to 12 months

Secondary outcomes

Percent of Common Toxicities Observed
Analyses 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.
Time frame: Through 30 days after the last dose of study drug, up to 3 years
Time to Radiographic Disease Progression for Patients With Recurrent Prostate Cancer Treated With Phenelzine.
Time frame: Through study completion, up to 3 years.

Results

Posted Jun 25, 2026

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 flow — Overall Study
Milestone	Treatment (Phenelzine Sulfate)
Started	26
Completed	20
Not completed	6
Withdrew: Adverse event	1
Withdrew: Physician decision	1
Withdrew: Withdrawal by subject	4

Outcome measures

PrimaryNumber of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate

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.

Time frame:: Baseline to up to 12 months
Reported as:: Count of participants · Participants

Number of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate
Participants	Treatment (Phenelzine Sulfate)
Number of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate	1

PrimaryNumber of Patients With PSA Decline of >= 30% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate

A 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.

Time frame:: Baseline to up to 12 months
Reported as:: Count of participants · Participants

Number of Patients With PSA Decline of >= 30% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate
Participants	Treatment (Phenelzine Sulfate)
Number of Patients With PSA Decline of >= 30% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate	4

SecondaryPercent of Common Toxicities Observed

Analyses 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.

Time frame:: Through 30 days after the last dose of study drug, up to 3 years
Reported as:: Number · percentage of participants

Percent of Common Toxicities Observed
percentage of participants	Treatment (Phenelzine Sulfate)
dizziness, grade 1	45
dizziness, grade 2	35
hypertension, grade ≥ 2	30
edema, grade 1	25
edema, grade 2	10

SecondaryTime to Radiographic Disease Progression for Patients With Recurrent Prostate Cancer Treated With Phenelzine.

Time frame:: Through study completion, up to 3 years.
Reported as:: Median · Months

Time to Radiographic Disease Progression for Patients With Recurrent Prostate Cancer Treated With Phenelzine.
Months	Treatment (Phenelzine Sulfate)
Time to Radiographic Disease Progression for Patients With Recurrent Prostate Cancer Treated With Phenelzine.	NA (NA to NA)

Adverse events

Collected over Through 30 days after final dose of study drug, up to 3 years.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Treatment (Phenelzine Sulfate)	1/26 (3.8%)	8/26 (30.8%)	26/26 (100%)

Most frequent serious events

Most frequent serious events
Event	Treatment (Phenelzine Sulfate)
SyncopeNervous system disorders	2/26
HypertensionVascular disorders	2/26
ConstipationGastrointestinal disorders	1/26
DiarrheaGastrointestinal disorders	1/26
Weight gainInvestigations	1/26
HypotensionVascular disorders	1/26

Most frequent other events

Showing 10 of 25

Most frequent other events
Event	Treatment (Phenelzine Sulfate)
DizzinessNervous system disorders	16/26
FatigueGeneral disorders	8/26
Dry mouthGastrointestinal disorders	7/26
Edema limbsGeneral disorders	7/26
SomnolenceNervous system disorders	6/26
ConfusionPsychiatric disorders	6/26
HypertensionVascular disorders	4/26
ConstipationGastrointestinal disorders	3/26
HeadacheNervous system disorders	3/26
Movements involuntaryNervous system disorders	3/26

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Treatment (Phenelzine Sulfate)
<=18 years	0
Between 18 and 65 years	8
>=65 years	18

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment (Phenelzine Sulfate)
Female	0
Male	26

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Treatment (Phenelzine Sulfate)
Hispanic or Latino	2
Not Hispanic or Latino	24
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Treatment (Phenelzine Sulfate)
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	1
White	25
More than one race	0
Unknown or Not Reported	0

Region of Enrollment
Region of Enrollment(participants)	Treatment (Phenelzine Sulfate)
United States	26

Study locations

4 sites

USC Norris Westside Cancer Center
Beverly Hills, California 90211, United States
Los Angeles County-USC Medical Center
Los Angeles, California 90033, United States
USC Norris Comprehensive Cancer Center
Los Angeles, California 90033, United States
Keck Medical Center of USC Pasadena
Pasadena, California 91105, United States

References and documents

Publications

Steib A, Pohoczky K, Toth N, Kormos V, Kun J, Kalai T, Mangel L, Matyus P, Helyes Z. The MAO-B Inhibitor Selegiline Reduces the Viability of Different Prostate Cancer Cell Lines and Enhances the Effects of Anti-Androgen and Cytostatic Agents. Pharmacol Res Perspect. 2025 Oct;13(5):e70173. doi: 10.1002/prp2.70173. PubMed 40932155 ↗

Study documents

Protocol and statistical analysis plan · Jan 7, 2016

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02217709
Lead sponsor: University of Southern California
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Aug 15, 2014
Start date: Sep 8, 2014
Primary completion: Jun 29, 2020
Completion: Jun 29, 2020
Results posted: Jun 25, 2026
Last update: Jun 25, 2026

Study contacts

Mitchell Gross, MD

principal investigator · University of Southern California

Jean C. Shih, PhD

principal investigator · University of Southern California

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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