Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02217709
Other study ID # 4P-14-1
Secondary ID NCI-2014-01791HS
Status Completed
Phase Phase 2
First received
Last updated
Start date September 8, 2014
Est. completion date June 29, 2020

Study information

Verified date December 2022
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 30 mg by mouth (PO) twice daily (BID) (starting dose of 15 mg daily escalated to 30 mg BID over 16 plus or minus 5 days). Patients who have been treated at 30 mg BID for over 3 cycles with resolution of any and all toxicities to grade < or = 1 may increase the dose to a maximum of 45 mg BID at the discretion of the treating investigator. Treatment may continue 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date June 29, 2020
Est. primary completion date June 29, 2020
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
phenelzine sulfate
Given by mouth
Other:
laboratory biomarker analysis
Correlative studies
questionnaire administration
Ancillary studies

Locations

Country Name City State
United States USC Norris Westside Cancer Center Beverly Hills California
United States Los Angeles County-USC Medical Center Los Angeles California
United States USC Norris Comprehensive Cancer Center Los Angeles California
United States Keck Medical Center of USC Pasadena Pasadena California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of PSA decline to >= 50% from baseline following at least 12 weeks of treatment with phenelzine sulfate Assessed independently in two groups of patients defined according to circulating androgen levels as: non-castrate and castrate. Baseline to up to 12 months
See also
  Status Clinical Trial Phase
Completed NCT03077659 - Trial of NanoPac® Focal Therapy in Subjects With Prostate Cancer Phase 2
Active, not recruiting NCT03624660 - Dose-Escalated Proton Radiation Therapy for High-Risk Prostate Cancer N/A
Completed NCT01054079 - Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer Phase 2
Terminated NCT00512668 - Hormone Therapy and Temsirolimus in Treating Patients With Relapsed Prostate Cancer Phase 1
Completed NCT00087139 - Ixabepilone in Treating Patients With Metastatic Prostate Cancer Phase 2
Completed NCT00182052 - Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer Phase 3
Active, not recruiting NCT03511196 - Intermittent Androgen Deprivation Therapy for Stage IV Castration Sensitive Prostate Cancer Early Phase 1
Active, not recruiting NCT01655836 - High-Dose Rate Brachytherapy and Stereotactic Body Radiation Therapy in Treating Patients With Prostate Cancer Phase 1
Terminated NCT03535675 - Muscadine Plus (MPX) In Men With Prostate Cancer Phase 3
Terminated NCT01866423 - Orteronel in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 2
Completed NCT02234921 - Pilot Study of DRibble Vaccine for Prostate Cancer Patients Phase 1
Completed NCT01468532 - Docetaxel, Prednisone, and Pasireotide in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT03686683 - Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer Phase 3
Active, not recruiting NCT03689699 - Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) Phase 1/Phase 2
Recruiting NCT04694924 - Prospective Prostate Cancer and Patient-reported Outcomes Registry
Active, not recruiting NCT04909294 - Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma N/A
Completed NCT02225925 - Intraoperative Dosimetry for Prostate Brachytherapy Using Fluoroscopy and Ultrasound N/A
Completed NCT01949519 - Docetaxel and Lycopene in Metastatic Prostate Cancer Phase 1
Completed NCT01433913 - Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery Phase 2
Completed NCT01228084 - Sulforaphane in Treating Patients With Recurrent Prostate Cancer Phase 2