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Could a depression drug fight prostate cancer?

NCT ID NCT02217709

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested phenelzine sulfate (Nardil), an antidepressant, in 26 men with prostate cancer that returned after initial treatment but hadn't spread. The goal was to see if the drug could lower PSA levels, a marker of cancer activity. Researchers measured how many patients had a 50% or 30% drop in PSA after 12 weeks of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
phenelzine sulfate (Nardil), an antidepressant drug
What this could lead to
If it works, this could point toward a new treatment option for men with recurrent prostate cancer that hasn't spread.
What could go wrong
This is a small, early-phase trial with only 26 participants, so results may not apply to everyone. The drug is an antidepressant, and its cancer-fighting effects are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

26 people

The number who actually took part.

Started

Sep 2014

Finished

Jun 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Keck Medical Center of USC Pasadena

    Pasadena, California, 91105, 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

  • USC Norris Westside Cancer Center

    Beverly Hills, California, 90211, United States

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