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Adenocarcinoma of the ProstatePhase 2NCT02217709

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

A Phase 2 study testing phenelzine sulfate, laboratory biomarker analysis and questionnaire administration in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by University of Southern California at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
phenelzine sulfate, laboratory biomarker analysis and questionnaire administration
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
4 sitesUnited States
Study dates
8 Sep 2014to 29 Jun 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 20Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • USC Norris Westside Cancer Center

    Beverly Hills, California, 90211

  • Los Angeles County-USC Medical Center

    Los Angeles, California, 90033

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Keck Medical Center of USC Pasadena

    Pasadena, California, 91105

Other trials in United States

About this study

Official title: Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer

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:

  1. 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:

  1. 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:

  1. 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.

Being tested
phenelzine sulfate, laboratory biomarker analysis, questionnaire administration
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • phenelzine sulfateDrug

    Also called Nardil

    Given by mouth

  • laboratory biomarker analysisOther

    Correlative studies

  • questionnaire administrationOther

    Ancillary studies

Study groups in NCT02217709
Study groupRoleWhat they receive
Treatment (phenelzine sulfate)ExperimentalPatients 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.
Receives: Drug: phenelzine sulfate; Other: laboratory biomarker analysis; Other: questionnaire administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to up to 12 months

  2. 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.

    Measured: Baseline to up to 12 months

Secondary outcomes (2)

  1. 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.

    Measured: Through 30 days after the last dose of study drug, up to 3 years

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

    Measured: Through study completion, up to 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2014 (estimated)
  2. Study start8 Sep 2014
  3. Primary completion29 Jun 2020
  4. Study completion29 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02217709
Sponsor's protocol ID
4P-14-1
Other IDs
NCI-2014-01791, HS-14-00331, 4P-14-1, P30CA014089
Status last verified
Nov 2025
First submitted
13 Aug 2014
Last updated
25 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing phenelzine sulfate, laboratory biomarker analysis and questionnaire administration in people with Adenocarcinoma of the Prostate and Recurrent Prostate Cancer, run by University of Southern California at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With PSA Decline of >= 50% From Baseline Following at Least 12 Weeks of Treatment With Phenelzine Sulfate (time frame: Baseline to up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02217709, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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