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

This is an interventional treatment trial for Adenocarcinoma of the Prostate Read More

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