DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: University of Southern California
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Intervention: phenelzine sulfate (Drug); laboratory biomarker analysis (Other); questionnaire administration (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Southern California

Official(s) and/or principal investigator(s):
Mitchell Gross, Principal Investigator, Affiliation: University of Southern California


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.

Clinical Details

Official title: Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Occurrence of PSA decline to >= 50% from baseline following at least 12 weeks of treatment with phenelzine sulfate

Detailed description: PRIMARY OBJECTIVES: I. To assess the proportion of patients with biochemical recurrent prostate cancer (BCR-PC) treated with phenelzine (phenelzine sulfate) who achieve a prostate-specific antigen (PSA) decline of >= 50% from baseline. SECONDARY OBJECTIVES: I. To monitor potential toxicities and/or beneficial effects on quality of life of phenelzine in prostate cancer patients. II. To assess time to radiographic disease progression for patients with recurrent prostate cancer treated with phenelzine. III. To collect blood and other samples to study the relationship between MAO activity and prostate cancer. OUTLINE: Patients receive phenelzine sulfate by mouth (PO) once daily (QD) or twice daily (BID). Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 3 years.


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


- 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


- 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


- 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

Locations and Contacts

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

Additional Information

Starting date: September 2014
Last updated: June 30, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017