Could a depression drug fight prostate cancer?
NCT ID NCT02217709
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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26 people
The number who actually took part.
- Started
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Sep 2014
- Finished
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
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Keck Medical Center of USC Pasadena
Pasadena, California, 91105, United States
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Los Angeles County-USC Medical Center
Los Angeles, California, 90033, United States
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USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
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USC Norris Westside Cancer Center
Beverly Hills, California, 90211, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a custom vaccine train the body to fight prostate cancer?
- Glowing dye could light up hidden lymph nodes in prostate cancer surgery
- New PET scan technique could map hidden prostate cancer recurrences
- Immune-Boosting drug and vaccine aim to fight returning prostate cancer
- Targeted radiation plus hormone therapy may slow Low-Volume prostate cancer spread