Clinical Trials /

Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance

NCT03579654

Description:

This study will evaluate the safety and efficacy of a prostate cancer vaccine named Proscavax (Prostate-specific antigen(PSA) / Interleukin-2(IL-2) / Granulocyte-macrophage colony-stimulating factor(GM-CSF)) in patients with localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. The researchers are interested in evaluating the proportion of participants with prostate cancer progression at 2 years following administration of Proscavax or active surveillance, the effect of the vaccine on prostate-specific antigen (PSA) doubling time and the assessment of adverse events in these patients. Eligible patients in this study will include men who are 18 years and older and who have a previously untreated early stage prostate cancer regardless of the date of diagnosis.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Proscavax Vaccine in Patients With Localized Prostate Cancer vs Active Surveillance
  • Official Title: A Phase 2, Randomized Study of Proscavax, a PSA/IL-2/GM-CSF Vaccine, in Treatment-naive Patients With Clinically Localized Prostate Cancer Versus an Active Surveillance Strategy

Clinical Trial IDs

  • ORG STUDY ID: O17-11110
  • NCT ID: NCT03579654

Conditions

  • Prostate Cancer

Interventions

DrugSynonymsArms
ProscavaxArm 1 - Proscavax vaccine treatment

Purpose

This study will evaluate the safety and efficacy of a prostate cancer vaccine named Proscavax (Prostate-specific antigen(PSA) / Interleukin-2(IL-2) / Granulocyte-macrophage colony-stimulating factor(GM-CSF)) in patients with localized prostate cancer. The goal of the study is to determine if vaccine administration results in a change in the rate of prostate cancer progression when compared to a no-treatment control group of active surveillance patients. The researchers are interested in evaluating the proportion of participants with prostate cancer progression at 2 years following administration of Proscavax or active surveillance, the effect of the vaccine on prostate-specific antigen (PSA) doubling time and the assessment of adverse events in these patients. Eligible patients in this study will include men who are 18 years and older and who have a previously untreated early stage prostate cancer regardless of the date of diagnosis.

Detailed Description

      This study will have 2 arms and patients will be randomized 2:1 into the Proscavax treatment
      arm (Arm 1) versus the active surveillance arm (Arm 2).

      In study Arm 1, 6 doses of the vaccine will be administered intradermally at weeks 1, 2, 3,
      7, 11, and 15, followed by maintenance booster injections once every month which will
      alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at
      weeks 23, 31, 39) for 6 months.

      In study Arm 2, patients will undergo active surveillance and will not receive any Proscavax
      vaccine treatment.
    

Trial Arms

NameTypeDescriptionInterventions
Arm 1 - Proscavax vaccine treatmentExperimentalIn this arm, during the first 4 months of induction treatment, 6 doses of the Proscavax vaccine will be administered intradermally at weeks 1, 2, 3, 7, 11, and 15, followed by maintenance booster injections once every month which will alternate between low dose IL-2 alone (at weeks 19, 27 and 35) and Proscavax vaccine (at weeks 23, 31, 39) for 6 months.
  • Proscavax
Arm 2 - Active SurveillanceNo InterventionIn this arm, patients will undergo active surveillance and will not receive any Proscavax vaccine treatment.

    Eligibility Criteria

            Inclusion Criteria:
    
              1. Histologically confirmed adenocarcinoma of the prostate.
    
              2. Age ≥ 18 years.
    
              3. Clinically localized prostate cancer:
    
                   -  T1 (Cancer can only be seen under a microscope),
    
                   -  NX (Regional lymph nodes cannot be assessed) or N0 (Cancer cannot be seen in the
                      lymph nodes),
    
                   -  MX (Presence of distant metastasis cannot be assessed) or M0 (Cancer hasn't
                      spread to other parts of the body).
    
              4. No previous treatment for prostate cancer (including hormonal therapy, radiation
                 therapy, surgery, or chemotherapy).
    
              5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
    
              6. Patients must have the following laboratory values:
    
                   1. Absolute neutrophil count (ANC) > 1500/µL
    
                   2. Platelet count >100,000/µL
    
                   3. Hemoglobin > 10 g/dL
    
                   4. Bilirubin < 1.5 x upper limits of normal
    
                   5. Aspartate aminotransferase (AST) < 1.5 x upper limits of normal
    
                   6. Adequate estimated glomerular filtration rate (eGFR) > 30 mL/min per 1.73 m2
                      (adjusted for race)
    
              7. Patient consent has been obtained according to local Institutional Review Board for
                 acquisition of research specimens.
    
              8. Patient is accessible and compliant for follow-up.
    
              9. Prostate biopsy requirements:
    
                   1. If diagnosis was within one year of baseline visit, participant must have at
                      least one biopsy with at least 10 cores.
    
                   2. If diagnosis was more than 1 year prior to baseline visit, participant must have
                      a minimum of 2 biopsies, one of which must be within 2 years prior to baseline
                      visit. Patients must have been diagnosed with prostate cancer within 2 years of
                      randomization (no history of prostate adenocarcinoma in any biopsies taken more
                      than 2 years prior to randomization).
    
             10. Must have NCCN low or favorable-intermediate risk prostate cancer defined as:
    
                   -  <50% of cores involved with cancer for eligibility and 50% or greater of cores
                      involved with cancer progression. Only cores from standard TRUS biopsy (not
                      MRI-guided cores) will be counted towards the number of cores involved.
    
                   -  No primary Gleason pattern 4 (Gleason score 4+3) disease in any cores (TRUS or
                      MRI-guided)
    
                   -  PSA less than 20 ng/mL
    
                   -  No extracapsular extension (<T3)
    
             11. Patients with female partners of childbearing potential must use at least one form of
                 Investigator-approved contraception while on-study and for 30 days after their last
                 administration of study investigational therapy. Acceptable birth control options
                 include:
    
                   1. surgical sterilization (patient and/or patient's partner),
    
                   2. approved hormonal contraceptives or therapies (such as birth control pills,
                      Depo-Provera, or Lupron Depot),
    
                   3. barrier methods (such as a condom or diaphragm) used with a spermicide, and
    
                   4. an intrauterine device (IUD).
    
            Exclusion Criteria:
    
              1. Unwillingness or inability (such as coagulopathy) to undergo serial prostate biopsy.
    
              2. History of other malignancies, except: adequately treated non-melanoma skin cancer or
                 adequately treated superficial bladder cancer (Ta) or other solid tumors curatively
                 treated with no evidence of disease for > 5 years.
    
              3. Evidence of metastatic prostate cancer.
    
              4. Immune-compromised patients including but not limited to: systemic immune suppressive
                 medications within 6 weeks of enrolling; HIV-positive and below normal cluster of
                 differentiation 4 (CD4) lymphocytes (less than 500 cells per microliter). Patients
                 must be tested for HIV seropositivity and CD4 lymphocyte count to be eligible for the
                 study.
    
              5. Inability to give consent.
    
              6. Any condition that, according to the investigator, would make the patient an
                 inappropriate study candidate.
    
              7. Patients with significant cardiac disease including heart failure that meets New York
                 Heart Association (NYHA) class II and IV definitions, history of myocardial infarction
                 within 6 months of study entry, uncontrolled dysrhythmias.
    
              8. Patients with existing autoimmune disorders (IL-2 and GM-CSF carry risk of
                 exacerbating underlying autoimmune disorders).
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Prostate cancer progression measured by PSA test
    Time Frame:At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms
    Safety Issue:
    Description:Determine prostate cancer progression in patients receiving Proscavax vaccine (Arm 1) versus patients on active surveillance (Arm 2) by measuring change in PSA levels in patients in both arms

    Secondary Outcome Measures

    Measure:PSA doubling time
    Time Frame:At pre-study, and then every 3 months till 2 years, starting at week 7 for both arms
    Safety Issue:
    Description:Determine the time for the PSA level to double
    Measure:Assessment of Adverse Events
    Time Frame:From first injection until 30 days past the 24-month assessments
    Safety Issue:
    Description:Confirm safety and tolerability of Proscavax vaccine

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Not yet recruiting
    Lead Sponsor:OncBioMune Pharmaceuticals

    Trial Keywords

    • Prostate Specific Antigen
    • Immunotherapy

    Last Updated

    March 5, 2019