Clinical Trials /

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

NCT02217709

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer
  • Official Title: Phase 2 Trial of Phenelzine in Non-metastatic Recurrent Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: 4P-14-1
  • SECONDARY ID: NCI-2014-01791
  • SECONDARY ID: HS-14-00331
  • SECONDARY ID: 4P-14-1
  • SECONDARY ID: P30CA014089
  • NCT ID: NCT02217709

Conditions

  • Adenocarcinoma of the Prostate
  • Recurrent Prostate Cancer
  • Stage I Prostate Cancer
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer

Interventions

DrugSynonymsArms
phenelzine sulfateNardilTreatment (phenelzine sulfate)

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (phenelzine sulfate)ExperimentalPatients receive phenelzine sulfate by mouth QD or BID. Treatment continues for up to 12 months in the absence of disease progression or unacceptable toxicity.
  • phenelzine sulfate

Eligibility 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)

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Occurrence of PSA decline to >= 50% from baseline following at least 12 weeks of treatment with phenelzine sulfate
Time Frame:Baseline to up to 12 months
Safety Issue:
Description:Assessed independently in two groups of patients defined according to circulating androgen levels as: non-castrate and castrate.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Southern California

Last Updated

April 18, 2017