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

• Status: Active, not recruiting
• Trial end date: 2023-09-08
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Cancer Institute (NCI)
• Treatments: Phenelzine

Criteria

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