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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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)
- 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
USC Norris Westside Cancer Center, Beverly Hills, California 90211, United States; Recruiting
Olga Castellanos, Phone: 310-272-7653, Email: ocastell@usc.edu
Mitchell E. Gross, Principal Investigator
Los Angeles County-USC Medical Center, Los Angeles, California 90033, United States; Recruiting
Charlean Ketchens, RN, Phone: 323-226-8326, Email: Charlean.Ketchens@med.usc.edu
Mitchell E. Gross, Principal Investigator
USC Norris Comprehensive Cancer Center, Los Angeles, California 90033, United States; Recruiting
Elysse F. Ballon, LVN, Phone: 323-865-0464, Email: elyssefaye.ballon@med.usc.edu
Mitchell E. Gross, Principal Investigator
Keck Medical Center of USC Pasadena, Pasadena, California 91105, United States; Recruiting
Carol Jones, RN, Phone: 626-568-1622, Email: Carol.Jones@med.usc.edu
Mitchell E. Gross, Principal Investigator